ACNE- salicylic acid cream

ACNE by

Drug Labeling and Warnings

ACNE by is a Otc medication manufactured, distributed, or labeled by GREENBRIER INTERNATIONAL INC, HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

for the treatment of acne

WARNINGS

Warnings

For external use only.

Do not use if you have very sensitive skin or are sensitive to Salicylic Acid

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

Directions

Cleanse the skin thoroughly before applying medication. Apply cream directly on acne pimples. 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 as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day.

Other information

store at 20 to 25 C (66 to 77 F)

Inactive ingredients

carbomer, cetyl alcohol, dimethicone, glycerin, glycol stearate, methylparaben, propylene glycol, propylparaben, squalane, triethanolamine, water

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ACNE 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-1307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)	2 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-1307-1	1 in 1 BOX
1		43 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2013

Labeler - GREENBRIER INTERNATIONAL INC (610322518)

Registrant - HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED (547695235)

Establishment
Name	Address	ID/FEI	Business Operations
HUZHOU MINO DAILY CHEMICALS COMPANY LIMITED		547695235	manufacture(33992-1307)