FDA Label for Acne Gel Pen
View Indications, Usage & Precautions
Acne Gel Pen Product Label
The following document was submitted to the FDA by the labeler of this product Tiege Hanley. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - Purpose
Purpose.......Acne Treatment
Otc - Active Ingredient
Salicylic Acid 2%
Otc - 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
* Please review the disclaimer below.
