ACNE TONER BIOLEMENTS- salicylic acid cream

Acne Toner by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Biolelements

Acne Clearing System

Acne Toner

0.5% salicylic acid acne treatment

Hydrates, clears and eliminates excess oil

88 mL / 3 Fl Oz

INGREDIENTS AND APPEARANCE

ACNE TONER  BIOLEMENTS
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCERIN (UNII: PDC6A3C0OX)
WINE GRAPE (UNII: 3GOV20705G)
HONEY (UNII: Y9H1V576FH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PINEAPPLE (UNII: 2A88ZO081O)
LEMON (UNII: 24RS0A988O)
LIME (CITRUS) (UNII: 8CZS546954)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
GRAPEFRUIT (UNII: O82C39RR8C)
ORANGE (UNII: 5EVU04N5QU)
KIWI FRUIT (UNII: 71ES77LGJC)
PAPAYA (UNII: KU94FIY6JB)
GRAPEFRUIT OIL (UNII: YR377U58W9)
ELEMI (UNII: C13XI009KO)
ORANGE OIL (UNII: AKN3KSD11B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LAVANDIN OIL (UNII: 9RES347CKG)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-130-02	1 in 1 CARTON
1	NDC: 49825-130-01	88 mL in 1 BOTTLE
2	NDC: 49825-130-04	1 in 1 CARTON
2	NDC: 49825-130-03	236 mL in 1 BOTTLE

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
Cosmetic Enterprises Ltd		017701475	manufacture(49825-130)