VASELINE- clinical care eczema calming therapy cream lotion
Conopco, Inc. d/b/a/ Unilever

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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Vaseline Clinical Care Eczema Calming Therapy Cream

Description

VASELINE CLINICAL CARE ECZEMA CALMING THERAPY CREAM - (colloidal oatmeal) lotion

Drug Facts

Active ingredient
Colloidal Oatmeal (1%)

Purpose

Skin Protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to: eczema

Warnings

For external use only
When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.
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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults, adolescents, and children over 6 months of age: Apply to affected area as needed

Inactive ingredients

Water (Eau), Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Isopropyl Palmitate, Dimethicone, Triethanolamine, Glyceryl Stearate, Isopropyl Myristate, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Methylparaben, Magnesium Aluminum Silicate, Carbomer, Propylparaben, Stearamide AMP, Disodium EDTA, Hydroxystearic Acid.

Questions or comments?

1-800-457-7084

Packaging

Vaseline Eczema Therapy Cream

VASELINE
clinical care eczema calming therapy cream lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64942-1867
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCOL STEARATE (UNII: 0324G66D0E)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARAMIDE AMP (UNII: U3K8640346)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SHEA BUTTER (UNII: K49155WL9Y)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64942-1867-1	200 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/05/2021

Labeler - Conopco, Inc. d/b/a/ Unilever (001375088)