EQUALINE- 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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DRUG FACTS

ACTIVE INGREDIENT

DIMETHICONE 1.3%

PURPOSE

SKIN PROTECTANT

USES

TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD.

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS, OR IF SYMPTOMS LAST MORE THAN 7 DAYS, OR IF THEY CLEAR UP AND 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.

DIRECTIONS

APPLY AS NEEDED.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

INACTIVE INGREDIENTS:

AVENA SATIVA (OAT) KERNEL FLOUR, BENZYL ALCOHOL, CETYL ALCOHOL, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, GLYCERIN, ISOPROPYL PALMITATE, PETROLATUM, PHENOXYETHANOL, SODIUM CHLORIDE, WATER (AQUA).

QUESTIONS OR COMMENTS?

1-877-932-7948

LABEL COPY

IMAGE OF THE LABEL

EQUALINE 
dimethicone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-358
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 13 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
OATMEAL (UNII: 8PI54V663Y)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-358-12 354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/15/2013
Labeler - SUPERVALU INC. (006961411)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
Name Address ID/FEI Business Operations
APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(41163-358)

Revised: 1/2013
Document Id: d87439aa-11fa-4cf6-b878-1a41f49e27cf
Set id: 2db612bc-be28-4967-a8bb-44ddf504cfaa
Version: 1
Effective Time: 20130115
 
SUPERVALU INC.