ACNE CLEANSER- salicylic acid liquid

Acne Cleanser by

Drug Labeling and Warnings

Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Salicylic Acid (0.5%)..........Acne Treatment

PURPOSE

Purpose

Acne Treatment

INDICATIONS & USAGE

For treatment of acne

WARNINGS

Warnings

For external use only

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

WHEN USING

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

DOSAGE & ADMINISTRATION

Directions:

Wash affected area twice daily.

INACTIVE INGREDIENT

Other Ingredients:

Aqua, Sodium Methyl 2-Sulfolaurate, Disodium 2-Sulfolaurate, Glycerin, Ethoxydiglycol, Hydroxyethylcellulose, Guar Hydroxypropyltrimonium Chloride, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, *CO Glycerin, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid, Fragrance. *CO Certified Organic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.15 mg  in 230 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)
DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9905-1	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/19/2023

Labeler - Spa de Soleil (874682867)

Registrant - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9905)