Otc - Active Ingredient
Active Ingredient
Salicylic Acid 1.5%
Anti Acne Calming Corrector
FDA Label NDC 65903-272
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H2o Plus for the product Anti Acne Calming Corrector (NDC 65903-272). 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 - active ingredient, otc - purpose, warnings, otc - ask doctor/pharmacist, indications & usage, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
acne treatment
Warnings
Warnings
For external use only.
Otc - Ask Doctor/Pharmacist
Ask a doctor of pharmacist before use
if you are using other topical acne
medications at the same time or
immediately following use of this product.
This may increase dryness or irritation of
skin. If this occurs, only one medication
should be used unless directed by a doctor.
Indications & Usage
When using this product avoid contact
with eyes. If contact occurs, rinse
thoroughly with water.
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. If
excessive skin irritation develops or
increases, discontinue use and consult
a doctor.
Dosage & Administration
Directions
Cleanse the skin thoroughly before
applying medication. • 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.
Inactive Ingredient
Inactive Ingredients
Water (Aqua), SD Alcohol 40-B, Hamamelis
Virginiana (Witch Hazel) Bark/Leaf/Twig
Extract, Butylene Glycol, Glycerin, Glycolic
Acid, Sodium Lactate, Linoleamidopropyl
PG-Dimonium Chloride Phosphate,
Hydroxyethylcellulose, Sodium Hydroxide,
Fragrance (Parfum), Polysorbate 20,
Polyquaternium-10, Hydrolyzed Algin,
Linalool, Propylene Glycol, Sea Salt (Maris
Sal), Palmaria Palmata Extract, Crithmum
Maritimum Extract, Himanthalia Elongata
Extract, Gigartina Stellata Extract,
Macrocystis Pyrifera Extract, Zinc Sulfate
Otc - Questions
Questions? call 1-800-242-2284
M-F, 8am-6pm CST
Package Label.Principal Display Panel
picture of carton label aacc272.jpg
Picture Of Carton Label (Aacc272)
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