PETROLATUM JELLY- petrolatum jelly

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Available from:
CRYSTAL CURAM
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph final
Authorization number:
72886-6662-0, 72886-6662-3

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.

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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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