VASELINE INTENSIVE RESCUE CLINICAL THERAPY FRAGRANCE FREE- dimethicone lotion

Vaseline by

Drug Labeling and Warnings

Vaseline by is a Otc medication manufactured, distributed, or labeled by Conopco Inc. d/b/a Unilever. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Dimethicone (1%)

PURPOSE

Purpose

skin protectant

INDICATIONS & USAGE

Uses

● temporarily protects and helps relieve chapped or cracked skin● helps protect from the drying effects of wind and cold weather

WARNINGS

Warnings

For External Use Only

When using this product do not get into eyes.

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.

Do not use on   ● deep or puncture wounds  ● animal bites  ● serious burns

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

DOSAGE & ADMINISTRATION

Directions

apply as needed

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Mineral Oil, Steareth-21, Borago Officinalis Seed Oil, Glycine Soja (Soybean) Sterol, Petrolatum, Tocopheryl Acetate, Stearic Acid, Lecithin, Tapioca Starch, Stearyl Stearate, Sodium Chloride, Linoleic Acid, Linolenic Acid, Ethylene Brassylate, Methylparaben, Propylparaben, DMDM Hydantoin, Titanium Dioxide.

QUESTIONS

QUESTIONS & COMMENTS? Call 1-800-457-7084

PDP 6.8 fl. oz.

6.8 fl. oz. carton

INGREDIENTS AND APPEARANCE

VASELINE  INTENSIVE RESCUE CLINICAL THERAPY FRAGRANCE FREE
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
STEARETH-21 (UNII: 53J3F32P58)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
PETROLATUM (UNII: 4T6H12BN9U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STARCH, TAPIOCA (UNII: 24SC3U704I)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LINOLENIC ACID (UNII: 0RBV727H71)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1038-2	1 in 1 CARTON
1	NDC: 64942-1038-1	200 mL in 1 BOTTLE, PLASTIC
2	NDC: 64942-1038-3	50 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/23/2008

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