Smart Release Mandelic
FDA Label NDC 73110-103

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 73110-103). 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, use, warnings, 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

Active Ingredient

SALICYLIC ACID  .5%

Purpose

TREATMENT OF ACNE

Warnings

For External Use Only.

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.

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. This product contains Mandelic Acid that may increase. Your skin's sensitivity to the sun and the possibility of sunburn. Use a sunscreen, wear protective clothing and limit exposure to the sun using this product and for one week after you stop. Store at room temperature.

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

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