FDA.reportPublic FDA data

X-OUT Acne Control Body Pads

Manufacturer
The Proactiv Company, LLC | Topiderm Inc.
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:47:12

Label at a glance#

ProductX-OUT Acne Control Body Pads
Active ingredientSalicylic Acid
Label structure12 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

For external use only When using this product

SPL UNCLASSIFIED SECTION

  • 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

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ct Carton
30ct Carton

X OUT®

ACNE CONTROL BODY PADS

salicylic acid acne treatment

From the Makers of Proactiv®

CONTAINS: 30 PADS

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-07011410-070-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Alcohol3K9958V90MIACT
Allantoin344S277G0ZIACT
Ammonia5138Q19F1XIACT
Green Tea LeafW2ZU1RY8B0IACT
Edetate Disodium7FLD91C86KIACT
GlycerinPDC6A3C0OXIACT
Glycolic Acid0WT12SX38SIACT
Hamamelis Virginiana TopUDA30A2JJYIACT
ImidureaM629807ATLIACT
PanthenolWV9CM0O67ZIACT
Polysorbate 207T1F30V5YHIACT
Sodium BenzoateOJ245FE5EUIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
abd00fcc-64da-41ab-acee-cdc33adf52797452db0b-e914-43b4-8bc6-9917cb88fa1e2022-12-22WarningsExact identifier
spl set id: 7452db0b-e914-43b4-8bc6-9917cb88fa1e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.