ACNE BODY WASH- salicylic acid soap
Curology

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%

Purpose

Acne treatment

Uses

For the treatment of acne

Warnings

For external use only.

When using this product using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by doctor.

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Dampen skin and massage a thin layer onto the entire affected area, then rinse thoroughly.
Because drying of skin may occur, start with one daily application, then gradually increase to two or three times daily, if needed or directed by a doctor.
If excessive 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, Sodium C14-16 Olefin Sulfonate, Glycerin, Cocamidopropyl Betaine, Cocamidopropyl Dimethylamine, Polyglyceryl-4 Caprate, Polyglyceryl-6 Caprylate, Hydroxypropyl Methylcellulose, Phenoxyethanol, Sodium Chloride, Zinc Pyrithione, Sodium Hydroxide, Polyquaternium-7, Ethylhexylglycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sodium Benzoate

Principal Display Panel - 100 ml Bottle Label

Curology

Acne Body Wash

Gentle foaming formula

2% salicylic acid treatment

DERMATOLOGIST

FOUNDED DEVELOPED TESTED

100 ml/3.4 fl oz

Principal Display Panel - 100 ml Bottle Label

Principal Display Panel - 200 ml Bottle Label

Curology

Acne Body Wash

Gentle foaming formula

2% salicylic acid treatment

DERMATOLOGIST

FOUNDED DEVELOPED TESTED

200 ml/6.8 fl oz

Principal Display Panel - 200 ml Bottle Label

ACNE BODY WASH
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82575-100
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Cocamidopropyl Dimethylamine (UNII: L36BM7DG2T)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Polyglyceryl-4 Caprate (UNII: 3N873UN885)
Polyglyceryl-6 Caprylate (UNII: DGV8R54VG7)
Phenoxyethanol (UNII: HIE492ZZ3T)
Pyrithione Zinc (UNII: R953O2RHZ5)
Polyquaternium-7 (70/30 Acrylamide/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Tea Tree Oil (UNII: VIF565UC2G)
Sodium Chloride (UNII: 451W47IQ8X)
Edetic Acid (UNII: 9G34HU7RV0)
Sodium Benzoate (UNII: OJ245FE5EU)
Formaldehyde/Sodium Naphthalenesulfonate Copolymer (3000 MW) (UNII: 90D834OZUI)
Xanthan Gum (UNII: TTV12P4NEE)
Magnesium Nitrate (UNII: 77CBG3UN78)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Magnesium Chloride (UNII: 02F3473H9O)
Methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82575-100-10	100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/05/2022

ACNE BODY WASH
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82575-200
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Glycerin (UNII: PDC6A3C0OX)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Cocamidopropyl Dimethylamine (UNII: L36BM7DG2T)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Polyglyceryl-4 Caprate (UNII: 3N873UN885)
Polyglyceryl-6 Caprylate (UNII: DGV8R54VG7)
Phenoxyethanol (UNII: HIE492ZZ3T)
Pyrithione Zinc (UNII: R953O2RHZ5)
Polyquaternium-7 (70/30 Acrylamide/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Tea Tree Oil (UNII: VIF565UC2G)
Sodium Chloride (UNII: 451W47IQ8X)
Edetic Acid (UNII: 9G34HU7RV0)
Sodium Benzoate (UNII: OJ245FE5EU)
Formaldehyde/Sodium Naphthalenesulfonate Copolymer (3000 MW) (UNII: 90D834OZUI)
Xanthan Gum (UNII: TTV12P4NEE)
Magnesium Nitrate (UNII: 77CBG3UN78)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Magnesium Chloride (UNII: 02F3473H9O)
Methylisothiazolinone (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82575-200-20	200 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	12/05/2022

Labeler - Curology (104103284)

Revised: 12/2022

Document Id: bb5d1f07-5e72-47c9-8177-af941a026e30

Set id: 9e057f84-0b46-4ffc-a3bb-5bafc8f6baa5

Version: 1

Effective Time: 20221205

Curology