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:

Galentic Pharma (India) Priva Te Limited

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 200 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Helps treat and prevent diaper rash. - Dries the oozing and weeping of; - poison ivy - poison oak - poison sumac - conditions worsens - symptoms last more than 7 days or clear up and occur again in a few days, consult a physician. - over large areas of the body - if you are allergic to any of these ingredients - deep or puncture wounds - animal bites - serious burns

Authorization status:

OTC monograph final

Summary of Product characteristics

ZINC OXIDE- ZINC OXIDE OINTMENT
GALENTIC PHARMA (INDIA) PRIVA TE LIMITED
_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 OINTMENT
Section Text
Active Ingredient Purpose
Zinc Oxide (200mg in each gram) Skin Protectant
US ES :
Helps treat and prevent diaper rash.
Dries the oozing and weeping of;
poison ivy
poison oak
poison sumac
WARNINGS :
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT:
Do not get in eyes.
STOP USE AND ASK A DOCTOR IF:
conditions worsens
symptoms last more than 7 days or clear up and occur again in a few
days, consult a physician.
over large areas of the body
if you are allergic to any of these ingredients
DO NOT USE ON:
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN
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 with each diaper change, especially at
bedtime or anytime when exposure to
wet diapers may be prolonged
FOR POISON IVY, POISON OAK, POISON SUMAC:
apply liberally as often as needed
INACTIVE INGREDIENTS
Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White
Soft Paraffin
PRINCIPAL DISPLAY
Galzinc.jpg
ZINC OXIDE
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 38 2-0 51
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
20 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Galentic Pharma (India) Priva Te Limited
INGREDIENT NAME
STRE NG TH
CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)
CETETH-2 0 (UNII: I8 35H2IHHX)
LIGHT MINERAL O IL (UNII: N6 K578 7QVP)
PETRO LATUM (UNII: 4T6 H12BN9 U)
PACK