NIVAGEN ZINC OXIDE- zinc oxide ointment

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Disponibil de la:

Nivagen Pharmaceuticals, Inc.

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

OTC DRUG

Indicații terapeutice:

Skin Protectant USES   ■    Helps treat and prevent diaper rash ■    Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac

Statutul autorizaţiei:

OTC monograph final

Caracteristicilor produsului

NIVAGEN ZINC OXIDE - ZINC OXIDE OINTMENT
NIVAGEN PHARMACEUTICALS, INC.
_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._
----------
ZINC OXIDE OINTMENT USP
ACTIVE INGREDIENT(S)
Zinc Oxide 20%
USE(S)
Skin Protectant
USES
■ Helps treat and prevent diaper rash
■ Dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT ■ do not get into eyes
Stop use and ask a doctor if
■ conditionworsens
■ symptoms last more than 7 days or clear up and occur again within
a few days
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
DIRECTIONS
■ For diaper rash: Change wet and soiled diapers promptly, cleanse
the diaper area,
and allow to dry. Apply ointment liberally as often as necessary, with
each diaper
change, especially at bedtime or anytime when exposure to wet diapers
may be
prolonged.
■ For poison ivy, oak, and sumac: Apply as needed.
OTHER INFORMATION
■ Store at room temperature
■ Avoid excessiveheat
INACTIVE INGREDIENTS
Cetomacrogol 1000, Cetostearyl Alcohol, Light Liquid Paraffin, White
Soft Paraffin
PRINCIPAL DISPLAY PANEL
NIVAGEN ZINC OXIDE
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:75834-170
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
200 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:75834-170-
01
28.4 g in 1 TUBE; Type 0: Not a Combination
Product
05/10/2018
2
NDC:75834-170-
02
56.7 g in 1 TUBE; Type 0: Not a Combin