GALENTIC VITAMIN A D- petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Galentic Pharma (India) Priva Te Limited

INN (International Name):

PETROLATUM

Composition:

PETROLATUM .76 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- Helps treat and prevent diaper rash - Helps seal out wetness - Temporarily protects minor * cuts * scrapes * burns - Temporarily helps protect and help relieve chapped and cracked skin and lips - Helps prevent and protect from the drying effects of wind and cold weather - Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash - With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged - If condition worsens - symptoms last more than 7 days or clear up and occur again in a few days Do not use: - Deep or puncture wounds - animal bites - serious burns

Authorization status:

OTC monograph final

Summary of Product characteristics

GALENTIC VITAMIN A D- PETROLATUM 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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GALENTIC VITAMIN A D
Active Ingredient Purpose
White Petrolatum USP (76%) Skin Protectant
PURPOS E:
Helps treat and prevent diaper rash
Helps seal out wetness
Temporarily protects minor * cuts * scrapes * burns
Temporarily helps protect and help relieve chapped and cracked skin
and lips
Helps prevent and protect from the drying effects of wind and cold
weather
Helps prevent and protect chafed skin or minor skin irritations
associated with diaper rash
With each diaper change, especially at bedtime when exposure to wet
diapers may be prolonged
WARNINGS :
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT:
Do not get in eyes
STOP USE AND ASK A DOCTOR IF:
If condition worsens
symptoms last more than 7 days or clear up and occur again in a few
days
DO NOT USE:
Do not use:
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 as needed
OTHER INFORMATION:
Store at room temperature 15 deg C to 30 deg C 59 deg F to 86 deg F
Avoid excessive heat
INACTIVE INGREDIENTS:
Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D
PRINCIPAL DISPLAY PANEL
Galentic Vit AD.jpg
GALENTIC VITAMIN A D
petrolatum ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 38 2-0 0 3
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U)
PETROLATUM
.76 g in 1 g
INACTIVE INGREDIENTS
Galentic Pharma (India) Priva Te Limited
INGREDIENT NAME
STRE NG TH
VITA