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  5. Label Information: Smart Release Mandelic 8 Percent

FDA Label for Smart Release Mandelic 8 Percent

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTHER INFORMATION
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smart Release Mandelic 8 Percent Product Label

The following document was submitted to the FDA by the labeler of this product Skinclinical Ai, Llc. 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.

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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