BIOELEMENTS SPOTLESS CLEANSER- salicylic acid gel

Bioelements by

Drug Labeling and Warnings

Bioelements by is a Otc medication manufactured, distributed, or labeled by Bioelements Inc., United 1International, Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Bioelements

Acne Clearing System

Spotless Cleanser

88 mL / 3 Fl. Oz.

INGREDIENTS AND APPEARANCE

BIOELEMENTS  SPOTLESS CLEANSER
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-113
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 mL  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: 49825-113-02	1 in 1 BOX
1	NDC: 49825-113-01	88 mL in 1 BOTTLE
2	NDC: 49825-113-04	1 in 1 BOX
2	NDC: 49825-113-03	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/05/2010

Labeler - Bioelements Inc. (174813923)

Registrant - Bioelements Inc. (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
United 1International		807878116	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture