EQUALINE- salicylic acid paste 
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

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

IMAGE OF THE LABEL

EQUALINE 
salicylic acid paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-828
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
EDETATE SODIUM (UNII: MP1J8420LU)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
PUMMELO (UNII: ET1TN5W71X)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
AGAR (UNII: 89T13OHQ2B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(41163-828)

Revised: 7/2013
Document Id: d2d024e7-1cd8-4237-b45d-bee97853ec0f
Set id: 1e513e40-4c66-44b4-9e6c-bdd9a8b0b70a
Version: 1
Effective Time: 20130724
 
SUPERVALU INC.