PETROLATUM JELLY- petrolatum jelly

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

ASTONEA LABS PRIVATE LIMITED

Droga podania:

TOPICAL

Typ recepty:

OTC DRUG

Wskazania:

Skin Protectant - temporarily protects minor cuts, scrapes, burns and sunburn - temporarily protects and helps relieve chapped or cracked skin - helps protect from drying effect of wind and cold weather - helps treat and prevent diaper rash - help seal out wetness - condition worsens - symptoms last for more than 7 days or clean up and occur again in a few days - deep or puncture wounds - animal bites - serious burns

Status autoryzacji:

OTC monograph final

Charakterystyka produktu

PETROLATUM JELLY- PETROLATUM JELLY
ASTONEA LABS PRIVATE 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._
----------
ASTONEA 99.9%
_ACTIVE INGREDIENT_
White Petrolatum (99.9% w/w)
_PURPOSE_
Skin Protectant
_USES_
temporarily protects minor cuts, scrapes, burns and sunburn
temporarily protects and helps relieve chapped or cracked skin
helps protect from drying effect of wind and cold weather
helps treat and prevent diaper rash
help seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into the eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last for more than 7 days or clean up and occur again in a
few days
DO NOT USE ON
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away
_DIRECTIONS_
apply as needed
_INACTIVE INGREDIENT_
Fragrance
PACKAGE LABEL
ASTONEA LABS PRIVATE LIMITED
PETROLATUM JELLY
petrolatum jelly
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:77338-101
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
PETROLATUM
99.9 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:77338-101-
03
226 g in 1 JAR; Type 0: Not a Combination
Product
01/01/2023
2
NDC:77338-101-
05
368 g in 1 JAR; Type 0: Not a Combination
Product
01/01/2023
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph final
part347
10/11/2016
LABELER -
ASTONEA LABS PRIVATE LIMITED (878533295)
Revised: 1/2023