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%

Purpose

Skin Protectant

Uses

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)

Label

CREAMY PETROLEUM
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42669-222
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCOL STEARATE (UNII: 0324G66D0E)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42669-222-01	127 g in 1 TUBE; Type 0: Not a Combination Product	06/04/2016	08/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/04/2016	08/01/2023

Labeler - Davion, Inc. (174542928)

Registrant - Anicare Pharmaceuticals Pvt. Ltd. (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(42669-222)

Revised: 8/2023

Document Id: 01e2ae1a-c96d-6dd2-e063-6394a90a9d9e

Set id: 5765a387-f256-4936-8c8c-426d4996ab58

Version: 7

Effective Time: 20230801

Davion, Inc.