Label: NIXODERM UNGUENTO- salicylic acid ointment
Contains inactivated NDC Code(s)
NDC Code(s): 70344-001-01
- Packager: Laboratorios Incobra S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 10, 2016
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
DOSAGE & ADMINISTRATION
*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
*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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
salicylic acid ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70344-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BENZOIC ACID (UNII: 8SKN0B0MIM) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SULFUR (UNII: 70FD1KFU70) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70344-001-01 20 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/10/2016 Labeler - Laboratorios Incobra S.A. (880003157) Establishment Name Address ID/FEI Business Operations Laboratorios Incobra S.A. 880003157 manufacture(70344-001)