PROACTIV ACNE CLEARING BODY- salicylic acid spray

Proactiv Acne Clearing Body by

Drug Labeling and Warnings

Proactiv Acne Clearing Body by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, Sun Pharma Canada Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• avoid contact with eyes. if contact occurs rinse eyes thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
• clean the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other Information

Store at 20-25°C (68 - 77°F)

Inactive ingredients

Water, Ethanol, Propylene Glycol, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 80, Sodium Hydroxide, Denatonium Benzoate, Alcohol, Allantoin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.

Questions or comments?

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC, Hawthorne, NY 10532
Made in the USA of Foreign and Domestic Components
Questions? 1-800-950-4695 proactiv.com Proactiv is a
registered trademark of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv

ACNE

CLEARING

BODY SPRAY

ACNE TREATMENT

2% salicylic acid

3.4 FL. OZ. (100 mL)

INGREDIENTS AND APPEARANCE

PROACTIV ACNE CLEARING BODY 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-217
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
ALCOHOL (UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TEA TREE OIL (UNII: VIF565UC2G)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-217-01	1 in 1 BOX	04/17/2024
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	04/17/2024

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(11410-217)