Bioelements Spotless Cleanser

Dosage form: gel
Ingredients: SALICYLIC ACID 2mL in 100mL
Labeler: Bioelements Inc.
NDC Code: 49825-113

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.

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











Bioelements

Acne Clearing System

Spotless Cleanser

88 mL / 3 Fl. Oz.






BIOELEMENTS  SPOTLESS CLEANSER
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
COCAMIDOPROPYL BETAINE 
GLYCERIN 
LAURYL GLUCOSIDE 
SODIUM CITRATE 
PINEAPPLE 
PAPAYA 
PANTHENOL 
ALLANTOIN 
PEG-150 DISTEARATE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:49825-113-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:49825-113-0188 mL in 1 BOTTLE
2NDC:49825-113-041 BOTTLE (BOTTLE) 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/FEIOperations
United 1International807878116manufacture
Establishment
NameAddressID/FEIOperations
Bell International Laboratories967781555manufacture

Revised: 04/2012
 
Bioelements Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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