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
Acne Gel Pen Gel
FDA Label NDC 71714-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tiege Hanley for the product Acne Gel Pen (NDC 71714-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - keep out of reach of children, dosage & administration, otc - purpose, otc - active ingredient, otc - stop use, inactive ingredient, indications & usage, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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