AcNesic Acne Treatment

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.

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

920 Box
(click image for full-size original)

Bottle

920 Botl
(click image for full-size original)

Insert

920 Insert
(click image for full-size original)

res

ACNESIC ACNE TREATMENT
salicylic acid gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63347-920
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
BENZALKONIUM CHLORIDE
BUTYLENE GLYCOL
BUTYLPARABEN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
ETHYLPARABEN
GLYCERIN
HYALURONIC ACID
EGG SHELL MEMBRANE
ISOBUTYLPARABEN
METHYLPARABEN
PHENOXYETHANOL
POLYSORBATE 20
PROPYLENE GLYCOL
PROPYLPARABEN
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63347-920-01 1 BOTTLE, PUMP in 1 BOX contains a BOTTLE, PUMP
1 48 g in 1 BOTTLE, PUMP This package is contained within the BOX (63347-920-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/06/2021
Labeler — Blaine Labs Inc. (017314571)
Establishment
Name Address ID/FEI Operations
Blaine Labs Inc. 017314571 manufacture (63347-920)

Revised: 04/2021 Blaine Labs Inc.

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