Otc - Active Ingredient
Active Ingredient
Benzoyl Peroxide 5 %
Clear Cell Clarifying Acne Lotion
FDA Label NDC 62742-4208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Clear Cell Clarifying Acne (NDC 62742-4208). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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
Indications & Usage
Use:
For the treatment of acne
Warnings
Warning
For external use only
Otc - Do Not Use
Do not use if you
have very sensitive skin
are sensitive to benzoyl peroxide
Otc - When Using
When using this product
Skin irritaion and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs,only use one topical acne medication at a time
Avoid unnecessary sun exposure and use a sunscreen
Aviod contact with the eyes, lips, and mouth
Avoid contact with hair and dyed fabrics,which may be bleached by this product
Skin irritation may occur,characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration
Otc - Stop Use
Stop use and ask a doctor if
Irritation becomes severe
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
Dosage & Administration
Direction
Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer one to three time 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
Other Safety Information
Other information
Avoid storing at extreme temperatures (below 40°F and above 100°F)
Inactive Ingredient
Inactive ingredients
Water/Aqua/Eau,Aloe Barbadensis
Leaf Juice,Glycerin,Carbomer,
Sodium Citrate, Phenoxyethanol,
Tocopheryl Acetate, Kaolin,
Butylene Glycol, Sodium
Hydroxide, Caprylyl Glycol,
Melaleuca Alternifolia (Tea Tree)
Leaf Oil, Xanthan Gum, Arnica
Montana Flower Extract,
Ethylhexylglycerin,Hexylene
Glycol, Propanediol, PEG-8/SMDI
Copolymer,Eucalyptus Globulus
Leaf Oil, Diethylhexyl Sodium
Sulfosuccinate, Sodium Phytate,
Melia Azadirachta Leaf Extract,
Limonene, Cinnamimum Camphora
(Camphor) Bark Oil, Sodium
Benzoate, Camellia Sinensis Leaf
Extract, Oryza Savita (Rice) Bran
Extract, Boswellia Serrata
Extract, Honey Extract,
Dimethicone, Silica, Sorbitan
Stearate, PEG-40 Stearate,
Linalool, Aesculus Hippocastanum
(Horse Chestnut) Extract,
Anthemis Nobilis Flower Extract,
Oligopeptide-10, Crystalline
Silica, Potassium Sorbate.
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