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Nixoderm Unguento

Medically reviewed on February 12, 2018

Dosage form: ointment
Ingredients: SALICYLIC ACID 2g in 100g
Labeler: Laboratorios Incobra S.A.
NDC Code: 70344-001

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.

Active Ingredients:

Salicylic Acid 2%

Acne Treatment

Keep out of reach of children. If swallowed, contact physician or poison control center immediately.

For Skin Acne treatment

For relief, irritation, redness and of Acne

Indications:

*For the treatment of Acne.  Clears up acne pimples and blemishes, and allows skin to heal. Helpsprevent new pimples and blemishes from forming.

Directions:

*Clean the skin thoroughly before applying this product.

*Cover the entire affected area with a thing layer one to three times daily, then gradually increase to two or three time daily if needed or as directed by a doctor

*If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Warnings:

*For external use only.

*Avoid contact with eyes. If contact occurs, rinse thoroughly with water

When using this product

*Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use only topical acne medication at a time

*Do not use without consulting a doctor if the condition appears over a large portion of the body.

Store at room temperature.

Other Ingredients: beeswax, BHT, benzoic acid, petrolatum, polysorbate 80, sulfur, zinc oxide.

NIXODERM UNGUENTO 
salicylic acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70344-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
BUTYLATED HYDROXYTOLUENE 
BENZOIC ACID 
PETROLATUM 
POLYSORBATE 80 
SULFUR 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:70344-001-0120 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/10/2016
Labeler - Laboratorios Incobra S.A. (880003157)
Establishment
NameAddressID/FEIOperations
Laboratorios Incobra S.A.880003157manufacture(70344-001)

 
Laboratorios Incobra S.A.

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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