EQUALINE- salicylic acid paste

EQUALINE by

Drug Labeling and Warnings

EQUALINE by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC., APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EQUALINE 
salicylic acid paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-828
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-828-04	124 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/17/2013

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(41163-828)