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Name:Bioelementsspotless Cleanser
Manufacturer:Bioelements Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Spotless Cleanser

BIOELEMENTS SPOTLESS CLEANSER - salicylic acid cream 
Bioelements Inc.

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.

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Spotless Cleanser

Active Ingredient         Purpose

Salicylic Acid 2%              Acne Treatment Gel

Warnings:

-For external use only

-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.

-Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

Uses:

-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.

Directions:

-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), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Polyacrylate-1 Crosspolymer, Ananas Sativa (Pineapple) Extract, Carica Papaya ( Papaya) Extract, Allantoin, Panthenol, Sodium Hydroxide, Chlorphenesin, Methylisothiazolinone, Citric Acid

image of carton

Bioelements

Acne Clearing System

Spotless Cleanser

88 mL / 3 Fl. Oz.

image of front label


BIOELEMENTS  SPOTLESS CLEANSER
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-113
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-113-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-113-01)
1 NDC:49825-113-01 88 mL in 1 BOTTLE This package is contained within the BOX (49825-113-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 05/05/2010

Labeler - Bioelements Inc. (174813923)
Registrant - Bioelements Inc. (174813923)
Establishment
Name Address ID/FEI Operations
Bioelements Inc. 174813923 manufacture

Revised: 06/2010 Bioelements Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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