FDA Label for Theraspec Acne Cleanser
View Indications, Usage & Precautions
Theraspec Acne Cleanser Product Label
The following document was submitted to the FDA by the labeler of this product Salient Labs, 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
Benzoyl Peroxide 5%
Otc - Purpose
Acne medication
Use
for the treatment of acne
Warnings
For external use only
Otc - Do Not Use
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide
Otc - When Using
When using this product
- keep away from eyes, lips and mouth
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with hair, dyed fabric, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. lf irritation becomes severe, discontinue use: if irritation still continues, consult a doctor.
- using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.
Dosage & Administration
Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.
Inactive Ingredient
Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.
Package Label.Principal Display Panel
TheraSpec
Acne Cleanser
Principal Display Panel
221 ml
NDC: 52205-003-00
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