Anti-acne

Dosage form: lotion
Ingredients: Salicylic Acid 2g in 100g
Labeler: Biocosmetics Research Labs
NDC Code: 59735-312

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.

Anti-acne Lotion


Active Ingredient:

Salicylic Acid 2%


Purpose:

Acne Treatment Cream

Use:For the treatment of acne.  Clears up most of the acne blemishes, acne pimples, blackheads or whiteheads.


Warnings: 

For external use only.

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.


Directions:

Cleanse the skin thoroughly before applying the medication.  Cover the entire affected area with a thin layer 1-2 times daily.  Because excessive drying of the skin may occur, start with one application every other day, then gradually increase.  If bothersome dryness or peeling occurs, reduce application to once every other few days.


Sensitivity test for new user:

Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated above.


Other Ingredients:

Water, Methyl Gluceth-20, Isopropyl Myristate, Sorbitan Stearate, Cetyl Alcohol, Alcohol Denat, Triethanolamine, Caprylic/Capric Triglyceride, Dimethicone,
Sodium Polyacrylate, Ceteareth-20, Butylene Glycol, Ethylhexyl Stearate, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Mel (Honey Extract), Trideceth-6, Retinyl Palmitate, Tocopheryl Acetate, Hydroxyethylcellulose, Arnica Montana Flower Extract, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Iodopropynyl Butylcarbamate.

ANTI-ACNE 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid2 g  in 100 g
Packaging
#Item CodePackage Description
1NDC:59735-312-561 TUBE (TUBE) in 1 CARTON
156.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33301/23/2008
Labeler - Biocosmetics Research Labs (078870292)

Revised: 01/2008
 
Biocosmetics Research Labs

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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