Label: BIOELEMENTS SPOTLESS CLEANSER- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-113-01, 49825-113-02, 49825-113-03, 49825-113-04 - Packager: Bioelements Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 18, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient Purpose
Salicylic Acid 2% Acne treatment gel
-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.
Keep out of reach of children.
if swallowed, get medical help or contact poison control center right away
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.
-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 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOELEMENTS SPOTLESS CLEANSER
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) SODIUM CITRATE (UNII: 1Q73Q2JULR) PINEAPPLE (UNII: 2A88ZO081O) PAPAYA (UNII: KU94FIY6JB) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-113-02 1 in 1 BOX 1 NDC:49825-113-01 88 mL in 1 BOTTLE 2 NDC:49825-113-04 1 in 1 BOX 2 NDC:49825-113-03 236 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 05/05/2010 Labeler - Bioelements Inc. (174813923) Registrant - Bioelements Inc. (174813923) Establishment Name Address ID/FEI Business Operations United 1International 807878116 manufacture Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture
