WHITE PETROLATUM ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)

Available from:

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

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 1 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Uses: - temporary protection of minor - cuts - scrapes - burns - sunburn - chafed or chapped skin - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps protect from wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

                                WHITE PETROLATUM- WHITE PETROLATUM 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._
----------
WHITE PETROLATUM USP
ACTIVE INGREDIENT:
White Petrolatum USP 100%
PURPOS E:
Skin Protectant
US ES :
temporary protection of minor
cuts
scrapes
burns
sunburn
chafed or chapped skin
helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect from wetness
WARNINGS :
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
avoid contact with eyes
not to be applied over deep or puncture wounds, infections or
lacerations
STOP USE AND ASK A DOCTOR IF
the condition persists or gets worse
if a rash or other allergic reaction develops
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 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
OTHER INFORMATION:
store at room temperature 15°-30°C (59°-86°F)
do not sure if seal is broken or missing
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
Fougera
NDC 0168-0053-16
WHITE PETROLATUM USP
_Skin Protectant_
NET WT 453.6g (1 lb.)
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
Fougera
NDC 0168-0053-21
WHITE PETROLATUM USP
_Skin Protectant_
NET WT 28.35g (1 Oz)
®
®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
Fougera
NDC 0168-0053-21
WHITE
PETROLATUM USP
_Skin Protectant_
Soothes minor skin irritations due to:
minor burns - scrapes - abrasions
®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
Fougera
NDC 0168-0053-45
WHITE PETROLATUM USP
Skin Protectant
NET WT 5g (approx. 5/32 Oz)

                                
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