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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41163-358
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
OATMEAL 
BENZYL ALCOHOL 
CETYL ALCOHOL 
DISTEARYLDIMONIUM CHLORIDE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ISOPROPYL PALMITATE 
PETROLATUM 
PHENOXYETHANOL 
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-358-12354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/15/2013
Labeler - SUPERVALU INC. (006961411)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(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.