ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM- aluminum acetate

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
Aluminum Acetate (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)
Available from:
ZO Skin Health, Inc.
Prescription type:
OTC DRUG
Therapeutic indications:
- For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.
Authorization status:
OTC monograph final
Authorization number:
42851-088-06, 42851-193-06

ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM- aluminum acetate

ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ZO Skin Health Post Procedure Recovery System

Drug Facts

Active Ingredient

Purpose

Aluminum Sulfate Tetradecahydrate, 2850

Astringent

Calcium Acetate Monohydrate, 2016 mg

Astringent

Us es

For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics,

or jewelry.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

do not cover compress or wet dressing with plastic to prevent evaporation

in some skin conditions, soaking too long may overdry

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

dissolve 1 packet in 12 oz. of cool or warm water.

stir until fully dissolved; do not strain or filter.

The resulting mixture contains 0.45% aluminum acetate and is ready for use.

For use as a compress or wet dressing:

soak a clean, soft cloth in the solution

apply cloth loosely to affected area for 15 to 30 minutes

repeat as needed or as directed by a doctor

discard solution after each use

Inactive Ingredients

Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein,

®

When combined together in water, these ingredients form the

active ingredient aluminum acetate. See Directions

Potassium Sorbate, Chitosan.

Other Information

Store at controlled room temperature: 15-30°C (59-86°F), away from direct sunlight.

You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO SKIN HEALTH

BY ZEIN OBAGI MD

POST PROCEDURE RECOVERY SYSTEM

NDC 42851-193-06

POMATROL Soothing Ointment 50 mL / 1.7 Fl. Oz.

HYDRATING CRÈME Net Wt.113 g / 4 Oz.

SURFATROL Astringent Solution Powder 10 ea. Net Wt.6 g / 0.21 Oz.

US Patent No. 9,248,160

ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM

aluminum acetate kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:428 51-19 3

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-19 3-0 6

1 in 1 CARTON

0 1/31/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

50 mL

Pa rt 2

1 TUBE

113 g

Pa rt 3

1 PACKET

6 g

Part 1 of 3

ZO SKIN HEALTH POMATROL SOOTHING

cleansing (cold creams, cleansing lotions, liquids, and pads) ointment

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

Wa ter (UNII: 0 59 QF0 KO0 R)

INGR

HYDRO GENATED PO LYBUTENE ( 13 0 0 MW) (UNII: 7D1YQ9 Y5EZ)

INGR

Glycerin (UNII: PDC6 A3C0 OX)

INGR

Tribehenin (UNII: 8 OC9 U7TQZ0 )

INGR

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

INGR

Po lyg lyceryl-4 Iso stea ra te (UNII: 8 20 DPX33S7)

INGR

Triethylhexa no in (UNII: 7K3W1BIU6 K)

INGR

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

INGR

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

INGR

MAGNESIUM SULFATE, UNSPECIFIED FO RM (UNII: DE0 8 0 37SAB)

INGR

Hexyl La ura te (UNII: 4CG9 F9 W0 1Q)

INGR

BRO CCO LI (UNII: UOI4FT57BZ)

INGR

O ATMEAL (UNII: 8 PI54V6 6 3Y)

INGR

PANTHENO L TRIACETATE, ( +) - (UNII: 120 6 E8 9 6 1B)

INGR

Ethyl Lino lea te (UNII: MJ2YTT4J8 M)

INGR

Erythrito l (UNII: RA9 6 B9 54X6 )

INGR

Chlo rphenesin (UNII: I6 70 DAL4SZ)

INGR

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

INGR

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

INGR

O leyl Alco ho l (UNII: 172F2WN8 DV)

INGR

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

INGR

N-ACETYLTYRO SINE (UNII: DA8 G6 10 ZO5)

INGR

Amino pro pyl Dihydro g en Pho spha te (UNII: D5J0 Q2CM4V)

INGR

Pro line (UNII: 9 DLQ4CIU6 V)

INGR

UBIDECARENO NE (UNII: EJ27X76 M46 )

INGR

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

INGR

Asco rbic Acid (UNII: PQ6 CK8 PD0 R)

INGR

To co phero l (UNII: R0 ZB2556 P8 )

INGR

Adeno sine Tripho spha te (UNII: 8 L70 Q75FXE)

INGR

Diso dium Acetyl Gluco sa mine Pho spha te (UNII: SC8 9 MF712W)

INGR

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

INGR

So dium Benzo a te (UNII: OJ245FE5EU)

INGR

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

INGR

PO LYO XYL 3 5 CASTO R O IL (UNII: 6 D4M1DAL6 O)

INGR

PEG-12 Glyceryl La ura te (UNII: J0 7WW42G15)

INGR

HO MARINE HYDRO CHLO RIDE (UNII: 8 8 6 6 LNG6 1N)

INGR

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

INGR

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

COSMETIC

0 1/31/20 19

Part 2 of 3

ZO SKIN HEALTH HYDRATING CREME

lotions, oils, powders, and creams lotion

Product Information

Route of Administration

TOPICAL

Other Ingredients

Ingredient Kind

Ingredient Name

Quantity

INGR

Wa ter (UNII: 0 59 QF0 KO0 R)

INGR

Glycerin (UNII: PDC6 A3C0 OX)

INGR

Petro la tum (UNII: 4T6 H12BN9 U)

INGR

Distea ryldimo nium Chlo ride (UNII: OM9 573ZX3X)

INGR

Iso pro pyl Pa lmita te (UNII: 8 CRQ2TH6 3M)

INGR

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

INGR

Cetyl Alco ho l (UNII: 9 36 JST6 JCN)

INGR

SHEA BUTTER (UNII: K49 155WL9 Y)

INGR

O ATMEAL (UNII: 8 PI54V6 6 3Y)

INGR

O phio po g o n Ja po nicus Ro o t (UNII: 9 0 PS6 JV9 GZ)

INGR

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

INGR

Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC)

INGR

Asco rbic Acid (UNII: PQ6 CK8 PD0 R)

INGR

Tetra peptide-2 1 (UNII: 179 JUC43HU)

INGR

MYRISTO YL PENTAPEPTIDE-4 (UNII: PMA59 A6 9 9 X)

INGR

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

INGR

GLYCYRRHIZINATE DIPO TASSIUM (UNII: CA2Y0 FE3FX)

INGR

Ma lto dextrin (UNII: 7CVR7L4A2D)

INGR

Benza lko nium Chlo ride (UNII: F5UM2KM3W7)

INGR

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

INGR

So dium Chlo ride (UNII: 451W47IQ8 X)

INGR

Benzyl Alco ho l (UNII: LKG8 49 4WBH)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

113 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

COSMETIC

0 1/31/20 19

Part 3 of 3

ZO SKIN HEALTH SURFATROL ASTRINGENT SOLUTION

aluminum acetate powder

Product Information

Ite m Code (Source )

NDC:428 51-0 8 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aluminum Aceta te (UNII: 8 0 EHD8 I43D) (ALUMINUM CATION - UNII:3XHB1D0 32B)

Aluminum Acetate

48 6 6 mg in 6 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

O AT (UNII: Z6 J79 9 EAJK)

SO Y PRO TEIN (UNII: R44IWB3RN5)

WHEY (UNII: 8 6 17Z5FMF6 )

Po ta ssium So rba te (UNII: 1VPU26 JZZ4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-0 8 8 -0 6

6 g in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 1/31/20 19

ZO Skin Health, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt347

0 1/31/20 19

Labeler -

ZO Skin Health, Inc. (826468527)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa kLa b

79 0 530 9 76

LABEL(428 51-19 3) , MANUFACTURE(428 51-19 3) , PACK(428 51-19 3)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa ra mo unt

0 0 13210 58

MANUFACTURE(428 51-19 3) , PACK(428 51-19 3)

Revised: 5/2019

Similar products

Search alerts related to this product

View documents history

Share this information