X-OUT ACNE CONTROL BODY PADS- salicylic acid liquid

X-OUT Acne Control Body Pads by

Drug Labeling and Warnings

X-OUT Acne Control Body Pads by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, Topiderm 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.

Stop use and ask a doctor if

• irritation becomes severe.

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
• gently wipe affected area with pad
• if necessary, repeat with a clean pad to remove remaining traces of oil and dirt
• use daily as needed
• if bothersome dryness or peeling occurs, reduce application use

Inactive ingredients

alcohol denat., allantoin, ammonium hydroxide, camellia sinensis leaf extract, disodium EDTA, glycerin, glycolic acid, hamamelis virginiana (witch hazel) water, imidazolidinyl urea, panthenol, polysorbate 20, sodium benzoate, water

Questions or comments?

1-800-950-4695

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Distributed by The Proactiv Company, LLC.
El Segundo, CA 90245 XOut.com

Made in the USA of foreign and domestic components

X Out is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL

X OUT®

ACNE CONTROL BODY PADS

salicylic acid acne treatment

From the Makers of Proactiv®

CONTAINS: 30 PADS

INGREDIENTS AND APPEARANCE

X-OUT ACNE CONTROL BODY PADS 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-070
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 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Allantoin (UNII: 344S277G0Z)
Ammonia (UNII: 5138Q19F1X)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Glycolic Acid (UNII: 0WT12SX38S)
Hamamelis Virginiana Top (UNII: UDA30A2JJY)
Imidurea (UNII: M629807ATL)
Panthenol (UNII: WV9CM0O67Z)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-070-00	30 in 1 JAR	01/01/2020
1		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2020

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm Inc.		049121643	manufacture(11410-070)