ADVANCED ACNE SPOT TREATMENT- salicylic acid gel

Advanced Acne Spot Treatment by

Drug Labeling and Warnings

Advanced Acne Spot Treatment 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.

Flammable. Keep away from fire or flame.

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 used unless 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 skin thoroughly before applying.

-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 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.

STORAGE AND HANDLING

Other information store at room

temperature 68 - 86 F (20 - 30 C)

INACTIVE INGREDIENT

Inactive ingredients  alcohol, ammonia,

benzalkonium chloride, butylene glycol, dimethicone,

disodium EDTA, glycerin, hamamelis virginiana extract,

laureth-7, menthyl lactate, paraffin, phenoxyethanol,

polyacrylamide, portaluca oleracea extract, propylene

glycol, water, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED ACNE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58194-030
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 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
LAURETH-7 (UNII: Z95S6G8201)
METHYL LACTATE, (-)- (UNII: 0379G9C44S)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)
PURSLANE (UNII: M6S840WXG5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58194-030-01	1 in 1 CARTON
1		21 g in 1 TUBE; 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	01/11/2016

Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Weierya Daily Chemicals Factory		420359333	manufacture(58194-030)