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SKIN CARE EXTRA STRENGTH

Dosage form: lotion
Ingredients: DIMETHICONE 1mL in 100mL
Labeler: THE KROGER CO
NDC Code: 59450-315

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.

PurposeSkin Protectant

UsesHELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN

DirectionsAPPLY 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

24OZ Front and Back Labels: k24.jpg

SKIN CARE   EXTRA STRENGTH
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-315
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
STEARIC ACID 
GLYCOL STEARATE 
SUNFLOWER OIL 
SOY STEROL 
LECITHIN, SOYBEAN 
.ALPHA.-TOCOPHEROL ACETATE, D- 
VITAMIN A PALMITATE 
UREA 
SODIUM ISOSTEAROYL LACTYLATE 
SODIUM PYRROLIDONE CARBOXYLATE 
POTASSIUM LACTATE 
LACTIC ACID 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
MAGNESIUM ALUMINUM SILICATE 
CARBOMER 934 
STEARAMIDOETHYL DIETHYLAMINE 
ETHYLENE BRASSYLATE 
TROLAMINE 
CORN OIL 
EDETATE DISODIUM 
METHYLPARABEN 
DMDM HYDANTOIN 
BUTYLATED HYDROXYTOLUENE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:59450-315-24709 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/25/2010
Labeler - THE KROGER CO (006999528)

Revised: 06/2010
 
THE KROGER CO

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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