DAILY MOISTURIZING  WITH NATURAL COLLOIDAL OATMEAL- dimethicone lotion 
SUPERVALU INC

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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BACK LABEL - DRUG FACTS BOX

ACTIVE INGREDIENT

DIMETHICONE 1.25%

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

QUESTIONS/COMMENTS?

1 - 877 - 932 - 7948

DIRECTIONS

ADULTS AND CHILDREN OVER 2 YEARS: APPLY AS NEEDED.

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN.

INACTIVE INGREDIENTS

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

PACKAGE FRONT AND BACK LABELS

12 OZ FRONT AND BACK LABELS: equaline12.jpg12 OZ FRONT AND BACK LABELS

DAILY MOISTURIZING   WITH NATURAL COLLOIDAL OATMEAL
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-320
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.2500 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-320-12354 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/21/2010
Labeler - SUPERVALU INC (006961411)

Revised: 7/2010
Document Id: 3d8cd58b-d760-4ffd-b39c-615c64d5d93d
Set id: 1977d056-dd09-4edc-a36d-59dca07f476a
Version: 1
Effective Time: 20100721
 
SUPERVALU INC