ACNE TONER ACNE CLEARING SYSTEM- salicylic acid liquid

Acne Toner by

Drug Labeling and Warnings

Acne Toner by is a Otc medication manufactured, distributed, or labeled by Bioelements, Cosmetic Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                    Purpose

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

PURPOSE

For the treatment of acne

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

INDICATIONS & USAGE

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.

WARNINGS

For external use only

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Acne Toner - Acne Clearing System

88 mL / 3 Fl. Oz.

INGREDIENTS AND APPEARANCE

ACNE TONER  ACNE CLEARING SYSTEM
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-136
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	.5 g  in .5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-136-02	1 in 1 BOX	04/10/2015
1	NDC: 49825-136-01	88 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49825-136-04	1 in 1 BOX	04/10/2015
2	NDC: 49825-136-03	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	part358B	04/10/2015

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises		017701475	manufacture(49825-136)