Acne Toner

Acne Toner

Drug Labeling and Warnings

Drug Details

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ACNE TONER ACNE CLEARING SYSTEM- salicylic acid liquid 
Bioelements

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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Acne Toner

Active Ingredient                    Purpose

Salicylic Acid 0.5% ................. Acne Treament

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 occure if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

For external use only

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.

Water (Aqua, Eau), Glycerin, Hexylene Glycol, Pentylene Glycol, PEG-40 Hydrogenated Castor Oil, Trideceth-9, Vitis Vinifera (Grape) Fruit Extract, Honey (Mel) Extract (Miel Extrait de mile), Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Furit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Tetrahexyldecyl Ascorbate, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Oil, Lavandula Hybrida (Lavandin) Oil, Caprylic/Capric Triglyceride, Canarium Luzonicum Gum Nonvolatiles, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol

Acne Toner - Acne Clearing System

88 mL / 3 Fl. Oz.

primary


secondary

ACNE TONER  ACNE CLEARING SYSTEM
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49825-136
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID.5 g  in .5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
TRIDECETH-9 (UNII: X9HD79I514)  
WINE GRAPE (UNII: 3GOV20705G)  
HONEY (UNII: Y9H1V576FH)  
KIWI FRUIT (UNII: 71ES77LGJC)  
PAPAYA (UNII: KU94FIY6JB)  
PINEAPPLE (UNII: 2A88ZO081O)  
LEMON (UNII: 24RS0A988O)  
LIME (CITRUS) (UNII: 8CZS546954)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
PUMMELO (UNII: ET1TN5W71X)  
ORANGE (UNII: 5EVU04N5QU)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
ORANGE OIL (UNII: AKN3KSD11B)  
LAVANDIN OIL (UNII: 9RES347CKG)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ELEMI (UNII: C13XI009KO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49825-136-021 in 1 BOX04/10/2015
1NDC: 49825-136-0188 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 49825-136-041 in 1 BOX04/10/2015
2NDC: 49825-136-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B04/10/2015
Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises017701475manufacture(49825-136)

Revised: 1/2017
 
Bioelements


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