IMAGE ESSENTIALS OATMEAL MOISTURIZING- dimethicone lotion
KMART CORPORATION

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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DRUG FACTS

ACTIVE INGREDIENT

DIMETHICONE 1.25%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

STOP USE AND ASK A DOCTOR IF

CONDITION WORSENS, OR IF RASH OR IRRITATION DEVELOPS AND LASTS MORE THAN 7 DAYS, OR IF THEY CLEAR UP AND RECUR WITHIN A FEW DAYS

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222)

DIRECTIONS

APPLY AS NEEDED

INACTIVE INGREDIENTS

WATER (AQUA), GLYCERIN, DISTEARYLDIMONIUM CHLORIDE, PETROLATUM, ISOPROPYL PALMITATE, CETYL ALCOHOL, AVENA SATIVA (OAT) KERNEL FLOUR, SODIUM CHLORIDE, DMDM HYDANTOIN, SODIUM HYDROXIDE, BENZYL ALCOHOL, METHYLPARABEN, PROPYLPARABEN

LABEL COPY

IMAGE OF THE LABEL

IMAGE ESSENTIALS OATMEAL MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49738-320
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PETROLATUM (UNII: 4T6H12BN9U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
OATMEAL (UNII: 8PI54V663Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49738-320-18	532 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/25/2014

Labeler - KMART CORPORATION (008965873)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(49738-320)