FANOFI MICRONEEDLE ACNE SOOTHING PATCH- salicylic acid patch

FANOFI Microneedle Acne Soothing Patch by

Drug Labeling and Warnings

FANOFI Microneedle Acne Soothing Patch by is a Otc medication manufactured, distributed, or labeled by JY Company, POLLYVE Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 0.4%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

- For the treatment of Acne

DOSAGE & ADMINISTRATION

1) Clean the acne or pimple spot. 2) Apply Micro-needle Acne Soothing Patch to the targeted spot. 3) Please press the patch gently for 5-10 seconds. 4) You may feel a prick, but this is a normal reaction. 5) Remove the patch after at least 5 hours.

WARNINGS

For external use only
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. avoid contact with eyes. If contact occurs, flush thoroughly with water.

People with allergy to aspirin will react poorly to the Salicylic Acid.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Sodium Hyaluronate, Vitis Vinifera Seed Extract, Hamamelis Virginiana Extract, Olea Europaea Leaf Extract, Centella Asiatica Extract, Sucrose, Madecassoside, Ginsenosides, Eucalyptus Globulus Leaf Extract, Portulaca Oleracea Extract, Disodium EDTA, Copper Tripeptide-1, Rh-Oligopeptide-1, Houttuynia Cordata Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FANOFI MICRONEEDLE ACNE SOOTHING PATCH 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73483-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.012 mg  in 3 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SUCROSE (UNII: C151H8M554)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
GINSENOSIDES (UNII: 3K198YD54P)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
PURSLANE (UNII: M6S840WXG5)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
NEPIDERMIN (UNII: TZK30RF92W)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73483-001-02	9 in 1 PACKAGE	12/16/2019
1	NDC: 73483-001-01	3 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/16/2019

Labeler - JY Company (695640101)

Registrant - JY Company (695640101)

Establishment
Name	Address	ID/FEI	Business Operations
POLLYVE Co., Ltd.		694665104	manufacture(73483-001)