SPOTLESS CLEANSER BIOELEMENTS- salicylic acid cream

Spotless Cleanser by

Drug Labeling and Warnings

Spotless Cleanser by is a Otc medication manufactured, distributed, or labeled by Bioelements, Inc., Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

Bioelements

Acne Clearing System

Spotless Cleanser

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

INGREDIENTS AND APPEARANCE

SPOTLESS CLEANSER  BIOELEMENTS
salicylic acid cream

Product 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)