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EQUALINE by SUPERVALU INC.

Dosage form: paste
Ingredients: SALICYLIC ACID 20mg in 1mL
Labeler: SUPERVALU INC.
NDC Code: 41163-828

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

SALICYLIC ACID 2.0%

PURPOSE

ACNE TREATMENT

USES

FOR THE TREATMENT OF ACNE.

WARNINGS

FOR EXTERNAL USE ONLY.

ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A DOCTOR.

WHEN USING THIS PRODUCT

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

STOP USING THIS PRODUCT AND ASK DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

USE TWICE A DAY. WET FACE. APPLY TO HANDS WITH SOME WATER AND WORK INTO LATHER. GENTLY MASSAGE FACE AND RINSE THOROUGHLY.

INACTIVE INGREDIENTS:

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, GLYCERIN, COCAMIDOPROPYL BETAINE, OXIDIZED POLYETHYLENE, ACRYLATES CROSSPOLYMER-4, CHONDRUS CRISPUS (CARRAGEENAN), C12-15 ALKYL LACTATE, DISODIUM EDTA, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, CITRUS GRANDIS (GRAPEFRUIT) FRUIT EXTRACT, POLYQUATERNIUM-7, CAMELLIA SINENSIS LEAF EXTRACT, ASCORBYL PALMITATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, ANTHEMIS NOBILIS FLOWER EXTRACT, POLYSORBATE 20, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, SODIUM CHLORIDE, BENZALKONIUM CHLORIDE, BUTYLENE GLYCOL, SODIUM BENZOTRIAZOYL BUTYLPHENOL SULFONATE, AGAR, ALUMINA, MICA, TITANIUM DIOXIDE, SODIUM HYDROXIDE, RED 30 (73360), RED 40 (CI 16035), EXT. VIOLET 2 (CI 60730), FRAGRANCE (PARFUM). 

LABEL COPY

EQUALINE 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-828
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
GLYCERIN 
COCAMIDOPROPYL BETAINE 
POLYETHYLENE GLYCOLS 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CHONDRUS CRISPUS 
C12-15 ALKYL LACTATE 
EDETATE SODIUM 
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
PUMMELO 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) 
GREEN TEA LEAF 
ASCORBYL PALMITATE 
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE 
CHAMAEMELUM NOBILE FLOWER 
POLYSORBATE 20 
POLYVINYL ALCOHOL 
PROPYLENE GLYCOL 
SODIUM CHLORIDE 
BENZALKONIUM CHLORIDE 
BUTYLENE GLYCOL 
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE 
AGAR 
ALUMINUM OXIDE 
MICA 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
D&C RED NO. 30 
FD&C RED NO. 40 
D&C VIOLET NO. 2 
Packaging
#Item CodePackage Description
1NDC:41163-828-04124 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/17/2013
Labeler - SUPERVALU INC. (006961411)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41163-828)

Revised: 07/2013
 
SUPERVALU 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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