HEALTHY ACCENTS MOISTURE HEALING - dimethicone lotion 
DZA Brands LLC

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.

----------

BACK LABEL - DRUG FACTS BOX

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.jpg10OZ Front and Back Labels

HEALTHY ACCENTS  MOISTURE HEALING
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-315-10295 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/25/2010
Labeler - DZA Brands LLC (090322194)

Revised: 6/2010
Document Id: 76b37d06-79d5-47b6-bd43-2e894d12dd28
Set id: 3334f923-ed7d-4209-aad4-849d8d559569
Version: 1
Effective Time: 20100625
 
DZA Brands LLC