Isomers Clear Skin Acne Spot Treatment

Dosage form: gel
Ingredients: SALICYLIC ACID 0.02mL in 1mL
Labeler: Isomers Laboratories Inc
NDC Code: 64990-601

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

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Active Ingredient:

Salicylic Acid         2%

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Purpose:

Acne Treatment

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Stop use and ask doctor

If irritation becomes severe

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Keep out of reach of children

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Warnings :

  • For external use only
  • Keep away from eyes
  • Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin, if this occurs only one medication should be used.
  • In case of accidental ingestion seek professional assistance or contact a poison control center immediately

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Inactive Ingredients :

Purified Water, Propylene Glycol, Optunia Ficus Indica Stem Extract, Boerhavia Diffusa root Extract, Thermus Thermophilus Ferment, Glycerin, Pentylene Glycol, Zinc PCA, Hydroxyethyl Cellulose, Phenoxyethanol, Decylene Glycol, Sodium Stearoyl Lacylate, Sodium Hydroxide.


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ISOMERS CLEAR SKIN ACNE SPOT TREATMENT  
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64990-601
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
OPUNTIA FICUS-INDICA 
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
PHENOXYETHANOL 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:64990-601-0430 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/01/2010
Labeler - Isomers Laboratories Inc (253306799)
Registrant - Isomers Laboratories Inc (253306799)
Establishment
NameAddressID/FEIOperations
Isomers Laboratories Inc253306799manufacture

Revised: 03/2010
 
Isomers Laboratories Inc

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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