DIMETHICONE- body shield cream

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

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
McKesson
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Skin Protectant Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve chapped or cracked skin Stop use and ask a doctor if - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days
Authorization status:
OTC monograph final
Authorization number:
68599-0213-4

DIMETHICONE- body shield cream

McKes s on

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.

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Body Shield Dimethicone

Drug Facts

Active Ingredient

Dimethicone 5%

Purpose

Skin Protectant

Uses

for the treatment and/or prevention of diaper rash

temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only.

When using this product

do not get into eyes

Do not use on

deep or puncture wounds

animal bites

serious burns

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser

Apply cream liberally until entire area is covered

Apply as needed

Store at 40-95ºF (4-35ºC)

Inactive Ingredients:

Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,

Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,

Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin

B3),

Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch

Octenylsuccinate,

Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf

Extract,

Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,

Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic

Acid,

Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,

Tyrosine, Phenylalanine, Cysteine, Triethanolamine

Questions?

Call 1-800-777-4908

NDC 68599-0213-4

McKesson

Thera

DIMETHICONE BODY SHIELD

Provides mild skin protection against irritation from chapped or cracked skin.

Single Patient Use

NET CONTENTS 4 fl oz (118 mL)

MFR # 53-DS4

DIMETHICONE

body shield cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 59 9 -0 213

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

50 ug in 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

VALINE (UNII: HG18 B9 YRS7)

PHENYLALANINE (UNII: 47E5O17Y3R)

CYSTEINE (UNII: K8 48 JZ48 8 6 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

KUKUI NUT O IL (UNII: TP11QR7B8 R)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

DIMETHICO NE CRO SSPO LYMER ( 4 50 0 0 0 MPA.S AT 12 % IN CYCLO PENTASILO XANE) (UNII: UF76 20 L1W6 )

CALCIUM PANTO THENATE (UNII: 56 8 ET8 0 C3D)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

O CTENYLSUCCINIC ACID (UNII: 12UZE4X73L)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CARTHAMUS TINCTO RIUS ( SAFFLO WER) O LEO SO MES (UNII: 9 S6 0 Q7230 9 )

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PRO LINE (UNII: 9 DLQ4CIU6 V)

GLYCINE (UNII: TE76 6 0 XO1C)

ARGININE (UNII: 9 4ZLA3W45F)

ASPARTIC ACID (UNII: 30 KYC7MIAI)

ALANINE (UNII: OF5P57N2ZX)

LEUCINE (UNII: GMW6 7QNF9 C)

TYRO SINE (UNII: 42HK56 0 48 U)

METHIO NINE (UNII: AE28 F7PNPL)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

GINGER (UNII: C5529 G5JPQ)

LYSINE (UNII: K3Z4F9 29 H6 )

THREO NINE (UNII: 2ZD0 0 419 0 S)

GLUTAMIC ACID (UNII: 3KX376 GY7L)

ISO LEUCINE (UNII: 0 4Y759 0 D77)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

NIACINAMIDE (UNII: 25X51I8 RD4)

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

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

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

HISTIDINE (UNII: 4QD39 79 8 7E)

McKesson

SERINE (UNII: 452VLY9 40 2)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

LEVO MENO L (UNII: 24WE0 3BX2T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 59 9 -0 213-4

118 mg in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

0 8 /12/20 19

Labeler -

McKesson (023904428)

Revised: 8/2019

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