ACNE TREATMENT PADS- salicylic acid patch

Acne Treatment Pads by

Drug Labeling and Warnings

Acne Treatment Pads by is a Otc medication manufactured, distributed, or labeled by Shanghai Weierya Daily Chemicals Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 2%

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Uses  for the treatment of acne

WARNINGS

Warnings

For external use only.

Avoid contact with eyes & lip, if contact

occurs, flush throoughly with water.

Ask a doctor or pharmacist before using

other topical acne medications at the same time

or immediately following use of this product. May increase

dryness or irritation of the skin. If this occurs, only one

medication should be usedunless directed

by a doctor.

When using this product apply to affected

area only. Do not use on broken skin or

apply to large areas of the body.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If

swallowed, get medical help or contact a

Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

-Cleanse the skin thoroughly before applying medication

-Use the pad to wipe the entire affected area one to three times daily

-If bothersome dryness or peeling occurs, reduce application to once a day or every other day

-Do not peave pad on skin for an extended period of time.

STORAGE AND HANDLING

Other information  store at room

temperature 68 - 86 F (20 - 30 C)

INACTIVE INGREDIENT

Inactive ingredients  water, SD

alcohol, glycerin, trideceth - 8,

PEG-12 dimethicone, hamamelis virginiana

flower (witch hazel) water, disodium EDTA,

benzalkonium chloride, sodium hydroxide,

fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE TREATMENT PADS 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58194-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
TRIDECETH-8 (UNII: FZH06801NX)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58194-044-50	50 in 1 JAR	07/17/2016
1	NDC: 58194-044-01	2 mL 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	07/17/2016

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-044)