ASSURED ACNE CREAM- acne cream cream

ASSURED ACNE CREAM by

Drug Labeling and Warnings

ASSURED ACNE CREAM by is a Otc medication manufactured, distributed, or labeled by HANGZHOU MINO DAILY CHEMICALS CO.LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid  0.5%

Purpose

Acne Treatment

Warnings

For external use only

• flammable, keep away from fire and flame
• will produce serious gastric disturbances if taken internally
  

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

• do not get into eyes or mucous membranes
• use only in a well-ventilated area

Stop use and ask a doctor if condition persists or gets worse.

Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

Use

for the treatment of acne.

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.

When using this product, avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

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 occurs, reduce application to once a day.

Other information

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

Inactive ingredients

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

Package Label

Enter section text here

INGREDIENTS AND APPEARANCE

ASSURED ACNE CREAM 
acne cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35038-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	74.5 mL  in 100 mL
SQUALANE (UNII: GW89575KF9)	10 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5 mL  in 100 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	3.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	3 mL  in 100 mL
GLYCOL STEARATE (UNII: 0324G66D0E)	2 mL  in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O)	1 mL  in 100 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	.2 mL  in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	.1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	.1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35038-200-01	44 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/01/2010

Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU MINO DAILY CHEMICALS CO.LTD.		527974203	manufacture