FDA.reportPublic FDA data

All Acne Treatment

Manufacturer
Blaine Labs Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:27

Label at a glance#

ProductAll Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient  Salycilic Acid 0.5% 

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

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 SECTION

Warnings - For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 20º-25º C (68º-77º F)

DOSAGE & ADMINISTRATION SECTION

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 SECTION

QUESTIONS OR COMMENTS? 

800.307.8818 | DrBlaines.com

M-F, 8:00 am - 4:00 pm (PST)

Contact@BlaineLabs.com

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

All Acne BoxAll Acne Box

All Acne CanAll Acne Can

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN2
252296salicylic acid 0.005 MG/MG Topical GelSCD2
252296salicylic acid 0.5 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-130-01All Acne Treatment48 g in 1 BOTTLE, PUMPGEL482
63347-130-01All Acne Treatment1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-130ALL ACNE TREATMENT (SALICYLIC ACID) GEL [BLAINE LABS INC.]2Current NDC, Legacy NDC, 2 package rows20231222_ee85939e-64fc-4b18-af5b-6ebd7e14e572.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-13063347-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
EGG SHELL MEMBRANEN7QBR4212VIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
ndc (package): 63347-130-01
ndc (product): 63347-130
ndc11 (package): 63347013001
spl id: 665e9976-dd83-4b80-8f56-18140f5a1868
spl set id: ee85939e-64fc-4b18-af5b-6ebd7e14e572

Reported adverse events (FAERS/openFDA)#

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