PETROLATUM JELLY- petrolatum jelly

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
09-04-2019

Ingredientes activos:

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

Disponible desde:

CRYSTAL CURAM

Vía de administración:

TOPICAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

Skin protectant - temporarily protects minor cuts, scrapes, burns and sunburn - temporarily protects and helps relieve chapped or cracked skin - helps protect from the drying effects of wind and cold weather - helps treat and prevent diaper rash - helps 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

Estado de Autorización:

OTC monograph final

Ficha técnica

                                PETROLATUM JELLY- PETROLATUM JELLY
CRYSTAL CURAM
_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._
----------
CRYSTAL COCOA BUTTER
_ACTIVE INGREDIENT_
White Petrolatum (99.5% 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 the drying effects of wind and cold weather
helps treat and prevent diaper rash
helps seal out wetness
_WARNINGS:_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into 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
PETROLATUM JELLY
petrolatum jelly
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:728 8 6 -6 6 6 2
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
9 9 .5 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:728 8 6 -6 6 6 2-3
36 9 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
0 4/0 7/20 19
2
NDC:728 8 6 -6 6 6 2-0
170 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
0 4/0 7/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt347
0 4/0 7/20 19
LABELER -
CRYST AL CURAM (675483147)
CRYSTAL CURAM
Revised: 4/2019
                                
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