SPOTLESS CLEANSER BIOELEMENTS- 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

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.

Bioelements

Acne Clearing System

Spotless Cleanser

2% salicylic acid acne cleanser
Cleanses deep to clear and heal acne

Label

Secondary

Primary

SPOTLESS CLEANSER  BIOELEMENTS
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  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:49825-131-021 in 1 CARTON06/17/2013
1NDC:49825-131-0188 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49825-131-041 in 1 CARTON06/17/2013
2NDC:49825-131-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/17/2013
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories967781555manufacture(49825-131)

Revised: 1/2017
Document Id: 870c7bde-d419-40e7-8a36-b5c5d8faffd8
Set id: 25309185-7b7e-474f-abe7-fd00b6aef6e7
Version: 10
Effective Time: 20170123
 
Bioelements, Inc.