HEALTHY ACCENTS MOISTURE HEALING- dimethicone lotion

Healthy Accents by

Drug Labeling and Warnings

Healthy Accents by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DIMETHICONE 1.0%

WARNING

FOR EXTERNAL USE ONLY.

When using this product

AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN 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.

Purpose

Skin Protectant

Uses

HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN

Directions

APPLY AS NEEDED.

Inactive Ingredients

Water, White Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Sterols, Lecithin, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Urea, Collagen Amino Acids, Sodium Stearoyl Lactylate, Sodium PCA, Potassium Lactate, Lactic Acid, Cetyl Alcohol, Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Stearamide AMP, Ethylene Brassylate, Triethanolamine, Corn Oil, Disodium EDTA, Methylparaben, DMDM Hydantoin, BHT, Titanium Dioxide

Package Front and Back Labels

10 OZ Front and Back Labels: hac10.jpg

INGREDIENTS AND APPEARANCE

HEALTHY ACCENTS  MOISTURE HEALING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-315
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCOL STEARATE (UNII: 0324G66D0E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SOY STEROL (UNII: PL360EPO9J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
UREA (UNII: 8W8T17847W)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
LACTIC ACID (UNII: 33X04XA5AT)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CARBOMER 934 (UNII: Z135WT9208)
STEARAMIDOETHYL DIETHYLAMINE (UNII: 25FFJ4209Z)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
TROLAMINE (UNII: 9O3K93S3TK)
CORN OIL (UNII: 8470G57WFM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-315-10	295 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/25/2010

Labeler - DZA Brands LLC (090322194)