Label: SPOTLESS CLEANSER BIOELEMENTS- salicylic acid cream
- NDC Code(s): 49825-131-01, 49825-131-02, 49825-131-03, 49825-131-04
- 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 January 23, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredient Purpose
Salicylic Acid 2% Acne treatment
Uses
for the treatment of acne
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
When using this product: 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 one topical acne medication at a time.
Warnings
For external use only
Directions
Apply one pump to wet skin and massage over face avoiding eye area, rinse off.
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.
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INGREDIENTS AND APPEARANCE
SPOTLESS CLEANSER BIOELEMENTS
salicylic acid creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-131 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 g 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:49825-131-02 1 in 1 CARTON 06/17/2013 1 NDC:49825-131-01 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49825-131-04 1 in 1 CARTON 06/17/2013 2 NDC:49825-131-03 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/17/2013 Labeler - Bioelements, Inc. (174813923) Registrant - Bioelements, Inc. (174813923) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(49825-131)
