FDA.reportPublic FDA data

Proactiv ® Acne Clearing Body Spray

Manufacturer
The Proactiv Company, LLC | Topiderm Inc.
Effective date
2018-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:03:25

Label at a glance#

ProductProactiv Acne Clearing Body
Active ingredientSalicylic Acid
Label structure9 sections

Indications and uses

for the management of acne of the body, with the skin enhancement properties of glycolic acid

Dosage and administration

Spray the entire affected area of the body one to three times daily. Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

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

Uses

INDICATIONS & USAGE SECTION

for the management of acne of the body, with the skin enhancement properties of glycolic acid

Warnings

WARNINGS SECTION

For external use only

  • Direct spray away from face, especially eyes, lips, and mouth
  • If irritation develops, discontinue use and consult a doctor.
  • Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin.  if this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, seek professional assistance or contact a Poison Control Center immediately.
  • Flammable; keep tightly closed, away from flame and heat.
  • Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter, because some individuals may be more sensitive to sunlight.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray the entire affected area of the body one to three times daily.
  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycolic acid, ethyl alcohol, ammonium hydroxide, hamamelis virginiana (witch hazel) water, acetone, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA, benzoic acid

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245


Made in USA of Foreign and Domestic Components
Within USA 1-800-950-4695
proactive.com
Proactiv is a trademark of The Proactiv Company Sàrl

PA.LAB872

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label_image
label_image

proactiv®

ACNE
CLEARING
BODY SPRAY

 3 FL. OZ. 89 mL

salicylic acid acne medication

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-06111410-061-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Glycolic Acid0WT12SX38SIACT
Alcohol3K9958V90MIACT
Ammonia5138Q19F1XIACT
Hamamelis Virginiana Top WaterNT00Y05A2VIACT
Acetone1364PS73AFIACT
Polysorbate 207T1F30V5YHIACT
Sodium BenzoateOJ245FE5EUIACT
ImidureaM629807ATLIACT
Edetate Disodium7FLD91C86KIACT
Benzoic Acid8SKN0B0MIMIACT

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
6e4a4b4d-d8d6-44e9-b2d3-4011bf62f6097fd00a12-b3e6-4d70-bc02-d3c63ec91d0b2022-12-15WarningsExact identifier
spl set id: 7fd00a12-b3e6-4d70-bc02-d3c63ec91d0b

Reported adverse events (FAERS/openFDA)#

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