GERIGENTLE-VITAMINS A AND D- petrolatum ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Geri-Gentle Corporation

INN (International Name):

Petrolatum

Composition:

Petrolatum 0.93 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - Helps treat and prevent diaper rash - Helps seal out wetness - Temporarily protects minor cuts scrapes burns - cuts - scrapes - burns - Temporarily helps protect and relieve chapped and cracked skin or 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 wetness may be prolonged

Authorization status:

OTC monograph final

Summary of Product characteristics

GERIGENTLE-VITAMINS A AND D- PETROLATUM OINTMENT
GERI-GENTLE CORPORATION
_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._
----------
GERIGENTLE-VITAMINS A AND D
DRUG FACTS
ACTIVE INGREDIENT
White Petrolatum USP (93%w/w)
PURPOSE
Skin Protectant
USES
Helps treat and prevent diaper rash
Helps seal out wetness
Temporarily protects minor
cuts
scrapes
burns
Temporarily helps protect and relieve chapped and cracked skin or 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
wetness may be
prolonged
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
Do not get into eyes
STOP USE AND CONSULT A DOCTOR IF
condition worsens
symptoms last more than 7 days
symptoms clear up and reoccur in a few days
DO NOT USE ON
deep puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN! If swallowed, get medical help or
contact a Poison
Control Center immediately
DIRECTIONS FOR USE WITH DIAPER RASH
change wet and soiled diaper promptly
cleanse the diaper area and allow to dry
apply as needed
OTHER INFORMATION
store at 15°-30°C (59°-86°F)
avoid excessive heat and humidity
INACTIVE INGREDIENTS
Lanolin, Lavender Fragrance, Light Liquid Paraffin, Paraffin, Vitamin
A, Vitamin D, CI
12740
PRINCIPAL DISPLAY PANEL
GERIGENTLE-VITAMINS A AND D
petrolatum ointment
Geri-Gentle Corporation
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69771-105
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
0.93 g in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SOLVENT YELLOW 18 (UNII: L4SQI4K87S)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H