NIXODERM UNGUENTO- salicylic acid ointment

Nixoderm Unguento by

Drug Labeling and Warnings

Nixoderm Unguento by is a Otc medication manufactured, distributed, or labeled by Laboratorios Incobra S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Salicylic Acid 2%

PURPOSE

Acne Treatment

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIXODERM UNGUENTO 
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)