CREAMY PETROLEUM- petrolatum jelly

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

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Active ingredient:
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Available from:
Davion, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Skin Protectant - Temporarily protects minor cuts, scrapes, and burns - Temporarily protects and helps relieve chapped or cracked skin - Helps protect from the drying effects of wind and cold weather - Deep or puncture wounds - Animal bites - Serious burns - 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:
42669-222-01

CREAMY PETROLEUM- petrolatum jelly

Davion, 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.

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Creamy Petroleum Jelly

Active Ingredient

Petrolatum 30%

Purpos e

Skin Protectant

Us es

Temporarily protects minor cuts, scrapes, and burns

Temporarily protects and helps relieve chapped or cracked skin

Helps protect from the drying effects of wind and cold weather

Warnings :

For External Use Only

When using this product

avoid contact with eyes. If contact occurs, flush with water.

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 Poison Control Center right away.

Directions :

Apply as needed

Inactive ingredients

Water, Glycol Stearate, Stearic Acid, Cetyl Alcohol, Glycerin, PEG-100 Stearate, Titanium Dioxide,

Caprylic/Capric Triglyceride, DMDM Hydantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer,

Disodium EDTA, Potassium Hydroxide, Tocopheryl Acetate

Package Display

NDC 42669-222-01

meijer Compare to Vaseline Petroleum Jelly Cream

Creamy petroleum jelly

Fragrance Free

Vitamin E Enriched

NET WT 4.5 OZ (127 g)

CREAMY PETROLEUM

petrolatum jelly

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:426 6 9 -222

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Davion, Inc.

PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)

PETROLATUM

30 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCO L STEARATE (UNII: 0 324G6 6 D0 E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

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

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

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

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:426 6 9 -222-0 1

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

0 6 /0 4/20 16

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 6 /0 4/20 16

Labeler -

Davion, Inc. (174542928)

Registrant -

Davion, Inc. (174542928)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Davio n, Inc.

1745429 28

ma nufa c ture (426 6 9 -222)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Anicare Pharmaceuticals Pvt. Ltd

9 16 8 37425

ma nufa c ture (426 6 9 -222)

Revised: 10/2019

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