ENDIT ZINC OXIDE SKIN PROTECTANT- zinc oxide ointment

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Tersedia dari:

Endit Laboratories, Inc.

Rute administrasi :

TOPICAL

Jenis Resep:

OTC DRUG

Indikasi Terapi:

Skin Protectant Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness.

Status otorisasi:

OTC monograph final

Karakteristik produk

ENDIT ZINC OXIDE SKIN PROTECTANT- ZINC OXIDE OINTMENT
ENDIT LABORATORIES, INC.
----------
ENDIT! ZINC OXIDE SKIN PROTECTANT
ACTIVE INGREDIENT:
Zinc Oxide 20.00%
PURPOSE:
Skin Protectant
USES:
Helps treat and prevent rash associated with diaper use, incontinence,
or exposure to
feces and urine. Protects chafed skin due to diaper rash and helps
seal out wetness.
WARNINGS:
FOR EXTERNAL USE ONLY.
do not get in eyes. WHEN USING THIS PRODUCT
STOP USE AND ASK DOCTOR IF
Condition worsens.
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:
Change wet and soiled diapers promptly.
Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner
thighs), and
allow to dry.
Apply liberally as often as necessary with each diaper change,
especially at bedtime or
anytime when exposure to soiled dapers (feces, and/or urine) may be
prolonged.
OTHER INGREDIENTS:
Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol,
White Petrolatum
PACKAGE LABELING:
ENDIT ZINC OXIDE SKIN PROTECTANT
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:64068-402
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
20 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BORIC ACID (UNII: R57ZHV85D4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STARCH, CORN (UNII: O8232NY3SJ)
JUNIPER TAR (UNII: 1Q84T0P2G3)
LANOLIN (UNII: 7EV65EAW6H)
RESORCINOL (UNII: YUL4LO94HK)
PETROLATUM (UNII: 4T6H12BN9U)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:64068-402-
01
454 g in 1 JAR; Type 0: Not a Combination
Product
05/31/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC Monograph Drug
M016
05/31/2017
Endit Laboratories, Inc.
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