Other
Drug Facts
All Acne Treatment Gel
FDA Label NDC 63347-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product All Acne Treatment (NDC 63347-130). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient Salycilic Acid 0.5%
Otc - Purpose
Purpose
Acne Treatment
Indications & Usage
Uses ■ for the treatment of acne
■ clears acne pimples, blackheads,
whiteheads and blemishes ■ allows skin
to heal ■ helps prevent new acne
pimples, blackheads whiteheads, and
acne blemishec
Warnings
Warnings - For external use only
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If
swallowed get medical help or contact a
Poison Control Center (1-800-222-1222)
right away.
Other Safety Information
Other Information store in dry
area at 20°-25° C (68°-77° F)
Dosage & Administration
Directions ■ clean the skin
thoroughly before applying this product
■ start with1 application daily, then
gradually increase to 2 to 3 times daily if
needed
Otc - Questions
Inactive Ingredient
Inactive Ingredients Aloe
barbadensis leaf extract, aminomethyl
propanol, benzalkonium chloride, butylene
glycol, butylparaben, carbomer, decyl
glucoside, deionized water, ethylparaben,
glycerin, hyaluronic acid, hydrolyzed
eggshell membrane, isobutylparaben,
methylparaben, phenoxyethanol,
propylparaben
Product Label
Dr. Blaine's®
ALL ACNE
TREATMENT
FACE & BODY
CLEARS ACNE &
PREVENTS BREAKOUTS
1.7 OZ (48 g)
MANUFACTURED BY:
Blaine Labs, Inc.
11037 Lockport Place
Santa Fe Springs, CA 90670
res
* Please review the disclaimer below.
