Label: EQUALINE- dimethicone lotion 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    DIMETHICONE 1.3%

    PURPOSE

    SKIN PROTECTANT

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  • USES

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

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  • 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.

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  • DIRECTIONS

    APPLY AS NEEDED.

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

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  • INACTIVE INGREDIENTS:

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

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  • QUESTIONS OR COMMENTS?

    1-877-932-7948

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    EQUALINE 
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41163-358
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 13 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    OATMEAL  
    BENZYL ALCOHOL  
    CETYL ALCOHOL  
    DISTEARYLDIMONIUM CHLORIDE  
    ETHYLHEXYLGLYCERIN  
    GLYCERIN  
    ISOPROPYL PALMITATE  
    PETROLATUM  
    PHENOXYETHANOL  
    SODIUM CHLORIDE  
    WATER  
    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)
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