BIOELEMENTS SPOTLESS CLEANSER- salicylic acid gel 
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




-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

-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.


-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



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Bioelements

Acne Clearing System

Spotless Cleanser

88 mL / 3 Fl. Oz.




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BIOELEMENTS  SPOTLESS CLEANSER
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-113-021 in 1 BOX
1NDC:49825-113-0188 mL in 1 BOTTLE
2NDC:49825-113-041 in 1 BOX
2NDC:49825-113-03236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/05/2010
Labeler - Bioelements Inc. (174813923)
Registrant - Bioelements Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
United 1International807878116manufacture
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories967781555manufacture

Revised: 4/2012
Document Id: 87645f39-f53a-463a-b956-e4172f3ecdb2
Set id: 97d59626-8a37-4e9b-8074-0038b9626308
Version: 16
Effective Time: 20120418
 
Bioelements Inc.