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SAFEWAY by SAFEWAY INC.

Dosage form: lotion
Ingredients: DIMETHICONE 1.25mL in 100mL
Labeler: SAFEWAY INC.
NDC Code: 21130-320

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.

DRUG FACTS

ACTIVE INGREDIENT

DIMETHICONE 1.25%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED SKIN.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS. IF CONDITION WORSENS OR SYMPTOMS LAST FOR MORE THAN SEVEN DAYS OR CLEARS UP AND RE-OCCURS 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.

DIRECTIONS

ADULTS AND CHILDREN OVER 2 YEARS. APPLY AS NEEDED.

INACTIVE INGREDIENTS:

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

LABEL COPY



SAFEWAY 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-320
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1.25 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
DISTEARYLDIMONIUM CHLORIDE 
PETROLATUM 
ISOPROPYL PALMITATE 
CETYL ALCOHOL 
OATMEAL 
BENZYL ALCOHOL 
SODIUM CHLORIDE 
DMDM HYDANTOIN 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:21130-320-18532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/03/2012
Labeler - SAFEWAY INC. (009137209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 12/2011
 
SAFEWAY INC.

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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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