Label: ACNE TONER BIOLEMENTS- salicylic acid cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-130-01, 49825-130-02, 49825-130-03, 49825-130-04 - Packager: Bioelements, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 18, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
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INGREDIENTS AND APPEARANCE
ACNE TONER BIOLEMENTS
salicylic acid creamProduct 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)
