ACNE TONER BIOLEMENTS- 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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Active ingredient             Purpose

Salicylic Acid 0.5%         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

Use after cleansing, day and night, avoiding eye area. Apply to cotton pad and gently wipe over skin. Do not rinse. If dryness or peeling occurs, reduce usage to once a day.

Inactive ingredients

Water (Aqua, Eau), Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Sodium Hydroxide, Ananas Sativus (Pineapple) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia(Lavender) Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Citrus Grandis (Grapefruit) Peel Oil, Canarium Luzonicum Gum Nonvolatiles, Citrus Aurantium Dulcis (Orange) Oil, Caprylic/Capric Triglyceride, Lavandula Hybrida (Lavandin) Oil, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Phenoxyethanol.

label

primary

secondary

Biolelements

Acne Clearing System

Acne Toner

0.5% salicylic acid acne treatment

Hydrates, clears and eliminates excess oil

88 mL / 3 Fl Oz

ACNE TONER  BIOLEMENTS
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HAMAMELIS VIRGINIANA LEAF 
PENTYLENE GLYCOL 
HEXYLENE GLYCOL 
GLYCERIN 
WINE GRAPE 
HONEY 
SODIUM HYDROXIDE 
PINEAPPLE 
LEMON 
LIME (CITRUS) 
LAVANDULA ANGUSTIFOLIA FLOWER 
GRAPEFRUIT 
ORANGE 
KIWI FRUIT 
PAPAYA 
GRAPEFRUIT OIL 
ELEMI 
ORANGE OIL 
MEDIUM-CHAIN TRIGLYCERIDES 
LAVANDIN OIL 
TETRAHEXYLDECYL ASCORBATE 
ETHYLHEXYLGLYCERIN 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:49825-130-021 in 1 CARTON
1NDC:49825-130-0188 mL in 1 BOTTLE
2NDC:49825-130-041 in 1 CARTON
2NDC:49825-130-03236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/17/2013
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd017701475manufacture(49825-130)

Revised: 06/2013
Document Id: 23679559-cd69-4c2e-a8a0-47442234824b
Set id: 1966e710-fded-4d6b-a9cc-978cd6ace4a5
Version: 1
Effective Time: 20130617
 
Bioelements, Inc.