ZINC OXIDE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 200 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin protectant Uses:

Authorization status:

OTC monograph final

Summary of Product characteristics

ZINC OXIDE- ZINC OXIDE OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA 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._
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ZINC OXIDE
ACTIVE INGREDIENT:
Zinc Oxide (200 mg)
PURPOSE:
Skin protectant
USES:
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•
•
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WARNINGS:
If condition worsens or dose not improve within seven days, consult
physician.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
FOR EXTERNAL USE ONLY
AVOID CONTACT WITH EYES
DIRECTIONS:
•
•
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OTHER INFORMATION:
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helps treat and prevent diaper rash
dries the oozing and weeping of:
poison ivy
poison oak
poison sumac
For diaper rash:
change wet and soiled diapers promptly, allow to dry
apply ointment liberally with each diaper change, especially at
bedtime or anytime
when exposure to wet diapers may be prolonged. To dry the oozing and
weeping
of poison ivy, poison oak or poison sumac:
apply ointment liberally as often as needed
do not use if seal is punctured or is not visible
use cap to puncture seal
store at temperature
•
INACTIVE INGREDIENTS
mineral oil, white petrolatum, white wax
QUESTIONS OR COMMENTS? CALL TOLL FREE 1-800-645-9833
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
NDC 0168-0062-31
Fougera
ZINC OXIDE OINTMENT USP
NET WT 28.35g (1 Oz)
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
NDC 0168-0062-31
Fougera
ZINC OXIDE OINTMENT USP
do not exceed 30° C (86° F)
®
®
Skin Protectant
To reliably help soothe and protect chafed skin.
INDICATION: Helps and prevent diaper rash. Protects chafed skin due to
diaper rash
and helps protect from wetness. Dries the oozing and weeping of poison
ivy, poison oak
and poison sumac.
NET WT 28.35g (1 Oz)
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
Fougera
NDC 0168-0062-