ACNE SOLUTION- salicylic acid solution
Biometics Co.,Ltd.

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 Solution

Acne Solution

image description

Pyrithione Zinc

for the treatment of acne

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

Directions Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor.

Warnings For external use only When using this product When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication. If irritation occurs, start with one application daily, then gradually increase to two or three times daily if needed or directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three daily if needed or directed by a doctor.

Aloe Water, Saururus Chinensis Extract, Camellia Sinensis Leaf Extract, Broussonetia Extract, Morus Alba Extract, Eucommia Ulmoides Extract, Phellodendron Amurense Bark Extract, Vitis Vinifera (Grape) Seed Oil, Lotus Seed Oil, Corylus Avellana (Hazel) Seed Extract, Allantoin, Centella Asiatica Extract, Capsicum Annuum Fruit Extract, Ceramide Liquid, Rosmarinus Officinalis (Rosemary) Extract, Olive Oil PEG-7 Esters, Citrus Paradisi (Grapefruit) Seed Extract, Paeonia Suffruticosa Root Extract, Water(and)Butylene Glycol(and)Propylene Glycol(and)Gleditsia Australis Fruit Extract(and)Cimicifuga racemosa Root Extract(and)Angelica Dahurica Root Extract, Bletilla hyacinthina Bulb Extract, Oryza Sativa(Rice) Bran Extract, Phaseolus, Angularis Seed Extract, Citrullus Colocynthis Fruit Extract, Propolis Extract, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Geranium Oil, Cymbopogon Martini Oil, Cupressus Sempervirens Oil

ACNE SOLUTION
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62818-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	salicylic acid	0.2 g in 40 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
SAURURUS CHINENSIS WHOLE (UNII: 6DRV3D37XS)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
BROUSSONETIA PAPYRIFERA WHOLE (UNII: 0QW22BU678)
MORUS ALBA WHOLE (UNII: C4228R0MX2)
EUCOMMIA ULMOIDES WHOLE (UNII: 21176878UY)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
LOTUS CORNICULATUS FLOWER VOLATILE OIL (UNII: W11376RO0T)
CORYLUS AVELLANA POLLEN EXTRACT (UNII: CR2J49TL6L)
ALLANTOIN (UNII: 344S277G0Z)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CAPSICUM ANNUUM WHOLE (UNII: 7FKZ3QQQ1F)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
OLIVE OIL (UNII: 6UYK2W1W1E)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
CYMBOPOGON MARTINI WHOLE (UNII: 267NPH931L)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62818-101-02	1 in 1 BOX
1	NDC:62818-101-01	40 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/01/2014

Labeler - Biometics Co.,Ltd. (689048850)

Registrant - Biometics Co.,Ltd. (689048850)

Name	Address	ID/FEI	Business Operations
Establishment
Biometics Co.,Ltd.		689048850	manufacture(62818-101)

Revised: 4/2014

Document Id: 041856fa-1f3e-4a4b-ba5a-f9326e9c620d

Set id: 3e7c306d-9927-4e7a-901f-abed8184fae4

Version: 1

Effective Time: 20140416

Biometics Co.,Ltd.