ROYAL PETROLEUM JELLY BABY FRESH SCENT BLUE- petrolatum jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Royal Exports

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - temporarily protects minor cuts, scrapes, burns - temporarily protects and helps relieve chapped or cracked skin - helps protect from 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 clear up and occur again within a few day - deep or puncture wounds - animal bites or serious burns

Authorization status:

OTC monograph final

Summary of Product characteristics

ROYAL PETROLEUM JELLY BABY FRESH SCENT BLUE- PETROLATUM JELLY
ROYAL EXPORTS
_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._
----------
_ACTIVE INGREDIENT_
White Petrolatum (99.9% w/w)
_PURPOSE_
Skin Protectant
_USES_
temporarily protects minor cuts, scrapes, burns
temporarily protects and helps relieve chapped or cracked skin
helps protect from 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 clear up and occur again within
a few day
_DO NOT USE ON_
deep or puncture wounds
animal bites or 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
ROYAL PETROLEUM JELLY BABY FRESH SCENT BLUE
petrolatum jelly
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:51328 -10 21
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 .9 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
Royal Exports
1
NDC:51328 -10 21-3
226 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
10 /10 /20 16
2
NDC:51328 -10 21-5
36 8 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
10 /10 /20 16
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
10 /10 /20 16
LABELER -
Royal Exports (650621381)
Revised: 1/2020