ACNE GEL PEN- salicylic acid gel

Acne Gel Pen by

Drug Labeling and Warnings

Acne Gel Pen by is a Otc medication manufactured, distributed, or labeled by Tiege Hanley. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
■ if swallowed, get medical help or contact
a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions ■ Twist bottom of pen to
release liquid. Apply liquid directly on
individual blemishes or clusters ■ Clean
the skin thoroughly before applying this
product ■ Cover the entire affected area
with a thin layer one to three times daily
■ Because excessive drying of the skin
may occur, start with one application daily,
then gradually increase to two or three
times daily if needed or as directed by a
doctor ■ If bothersome dryness or peeling
occurs, reduce application to once a day or
every other day

PURPOSE

Purpose.......Acne Treatment

ACTIVE INGREDIENT

Salicylic Acid 2%

STOP USE

Stop use and ask a doctor if irritation
becomes severe.

INACTIVE INGREDIENT

Inactive Ingredients:
Alcohol Denat., Hamamelis Virginiana (Witch
Hazel) Water, Polyvinylpyrrolidone, Alcohol,
Niacinamide, Water/Aqua/Eau, Sodium
Hydroxide, Phenoxyethanol, Melia
Azadirachta Leaf Extract, Bisabolol, Glycerin,
t-Butyl Alcohol, Melia Azadirachta Flower
Extract, Ethylhexylglycerin, Centella Asiatica
Extract, Zingiber Officinale (Ginger) Root
Extract

INDICATIONS & USAGE

Uses ■ For the management of acne

WARNINGS

Warnings
■ For External Use Only

When using this product ■ skin irritation
and dryness is more likely to occur if you
use another topical acne medication at the
same time. If irritation occurs, only use one
topical acne medication at a time.
Do not use if you ■ have very sensitive
skin ■ are sensitive to salicylic acid
Stop use and ask a doctor if irritation
becomes severe
Keep out of reach of children
■ if swallowed, get medical help or contact
a Poison Control Center right away

Flammable: Keep away from high heat
and flame

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE GEL PEN 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71714-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MELIA AZADIRACHTA LEAF (UNII: HKY915780T)
PVP (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
T-BUTYL ALCOHOL (UNII: MD83SFE959)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
ALCOHOL (UNII: 3K9958V90M)
BISABOLOL (UNII: 24WE03BX2T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CENTELLA ASIATICA (UNII: 7M867G6T1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71714-004-01	1.3 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	10/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	10/31/2025

Labeler - Tiege Hanley (080305325)