ASSURED ACNE CREAM

Dosage form: cream
Ingredients: SALICYLIC ACID .5mL in 100mL
Labeler: HANGZHOU MINO DAILY CHEMICALS CO.LTD.
NDC Code: 35038-200

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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

ASSURED ACNE CREAM 
acne cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35038-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER74.5 mL  in 100 mL
SQUALANE10 mL  in 100 mL
PROPYLENE GLYCOL5 mL  in 100 mL
CETYL ALCOHOL3.5 mL  in 100 mL
GLYCERIN3 mL  in 100 mL
GLYCOL STEARATE2 mL  in 100 mL
DIMETHICONE1 mL  in 100 mL
METHYLPARABEN.2 mL  in 100 mL
PROPYLPARABEN.1 mL  in 100 mL
TROLAMINE.1 mL  in 100 mL
Packaging
#Item CodePackage Description
1NDC:35038-200-0144 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/2010
Labeler - HANGZHOU MINO DAILY CHEMICALS CO.LTD. (527974203)
Establishment
NameAddressID/FEIOperations
HANGZHOU MINO DAILY CHEMICALS CO.LTD.527974203manufacture

Revised: 12/2010
 
HANGZHOU MINO DAILY CHEMICALS CO.LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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