Active Ingredient
SALICYLIC ACID .5%
Smart Release Mandelic
FDA Label NDC 73110-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Skinclinical Ai, Llc for the product Smart Release Mandelic (NDC 73110-104). 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 active ingredient, purpose, warnings, use, other information, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
TREATMENT OF ACNE
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 1 topical acne medication at a time.
Avoid unnecessary sun exposure and use a sunscreen.
Use
HELPS PREVENT SUNBURN. IF USED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS) DECREASES THE CHANCES OF SKIN CANCER AND EARLY SIGNES OF SKIN AGING CAUSED BY THE SUN.
Other Information
Keep tightly closed.
Protect from excessive heat (40°/ 140° F) and protect from freezing.
Otc - Stop Use
Stop use and ask a doctor if irritation or sensitivity develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poisorl fontrol Center right away.
Directions
Important to use on a clean face, Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day, one morning and one evening ff needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. if irritation or sensitivity develops stop using both products and ask a doctor.
Inactive Ingredients
Water (Agua), SD Alcohol 40-B, Mandelic Acid, Butylene Glycol,Hamamelis Virginiana (Witch Hazel) Leaf Water, Lactobacillus Ferment, PEG-8 SMDI Copolymer, Niacinamide, Lactic Acid, Sodium PCA, Sodium Lactate, Hydrolyzed Algin, Zinc Sulfate, Glycerin, Opuntia Ficus lndica (Nopal Cactus), Saccharomyces Cerevisiae (Yeast) Extract, Hydroxyethylcellulose, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Acer Saccharum (Sugar Maple) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oi!, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Tangerina (Tangerine) Peel Oil
Questions?
Call toll-free T 1-800-200-6365 or visit www.acneintellifillnce.com
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