AcNesic Acne Treatment  Rx Only

AcNesic Acne Treatment by

Drug Labeling and Warnings

AcNesic Acne Treatment by is a Prescription medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACNESIC ACNE TREATMENT- salicylic acid gel 
Blaine Labs Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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AcNesic Acne Treatment  Rx Only

DOSAGE AND ADMINISTRATION

Wash the affected skin with soap and water. Allow to dry
thoroughly. Apply a thin layer 1-3 times per day.

INDICATIONS AND USAGE

Indicated for the treatment of acne. Clears and prevents
acne pimples, blackheads, whiteheads and acne blemishes.

For external usage only. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN.

Store at room temperature 20°C-25°C (68°F-77°F).
For complete prescribing information, see package insert.

ACTIVE INGREDIENT
Salycilic Acid 0.5% (Acne Treatment).

INACTIVE INGREDIENTS
Aloe barbadensis leaf extract, benzalkonium chloride,
butylene glycol, butylparaben, carbomer, deionized water,
ethylparaben, glycerin, hyaluronic acid, hydrolyzed egg shell
membrane, isobutylparaben, methylparaben,
phenoxyethanol, polysorbate 20, propylene glycol,
propylparaben, triethanolamine.

Product Label

NDC: 63347-920-01

BLAINE LABS®​

AcNesic®​

ACNE TREATMENT

(SALICYLIC ACID 0.5%)

FOR TOPICAL USE ONLY

RX ONLY

1.7 OZ (48 g)

QUESTIONS OR COMMENTS?
800.307.8818 | BlaineLabs.com
M-F, 7:30 am - 3:30 pm (PST)
Contact@BlaineLabs.com

MANUFACTURED BY:
Blaine Labs, Inc.
11037 Lockport Place
Santa Fe Springs, CA 90670

25100-P-LBL01          REV20210409

Box

Bottle

Insert

res

ACNESIC ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63347-920
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONIC ACID (UNII: S270N0TRQY)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-920-01	1 in 1 BOX	04/06/2021
1		48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/06/2021	12/01/2022

Labeler - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-920)

Revised: 12/2022

Document Id: 20da8eb4-bb1d-44de-b657-8edfce4fcd81

34391-3

Set id: bc72f728-7cd0-46c3-9d70-55223b097cd2

Version: 2

Effective Time: 20221212