Otc - Active Ingredient
Active Ingredient Purpose
Salicylic Acid 2% Acne treatment gel
Salicylic Acid 2% Acne treatment gel
Bioelements
FDA Label NDC 49825-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioelements Inc. for the product Bioelements (NDC 49825-113). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
-For the treatment of acne
-Dries up acne pimples
-Helps prevent new acne pimples
-Reduces the number of acne pimples
-Penetrates pores to eliminate most acne blemishes
-Helps prevent new acne blemishes, blackheads and whiteheads.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
if swallowed, get medical help or contact poison control center right away
Indications & Usage
-For external use only
Warnings
When using this product: using other topical acne medication 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. If sensitive to the sun or when increased sun exposure is expected use a sunscreen when using this and other acne products.
Dosage & Administration
-Apply one pump to wet skin and massage over face avoiding eye area
-Use morning and night
-If dryness or peeling occurs, reduce usage to once a day
Inactive Ingredient
Inactive Ingredients: Water (Aqua, Eau), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Lauryl Glucose Carboxylate, Glycerin, Lauryl Glucoside, Sodium Citrate, Ananas Sativus (Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Panthenol, Allantoin, PEG-150 Distearate, Sodium Chloride
Image Of Carton (Carton)
Image Of Secondary (Secondary)
Image Of Temporary Label (Temp)
Package Label.Principal Display Panel
Bioelements
Acne Clearing System
Spotless Cleanser
88 mL / 3 Fl. Oz.
Image Of Front Label (Front)
Image Of Primary Label (Primary)
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