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 Huijing (Shanghai) Bio-tech Co., Ltd. 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,

alcohol, glycerin, trideceth - 8,

PEG-12 dimethicone, hamamelis virginiana

(witch hazel) flower 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: 71537-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	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: 71537-001-02	50 in 1 CONTAINER	06/23/2017
1	NDC: 71537-001-01	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	06/23/2017

Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337)

Establishment
Name	Address	ID/FEI	Business Operations
Huijing (Shanghai) Bio-tech Co., Ltd		544482337	manufacture(71537-001)