REXALL PETROLEUM WITH VITAMIN E AND ALOE- petrolatum jelly

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DOLGENCORP INC

INN (International Name):

PETROLATUM

Composition:

PETROLATUM 99.8 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- TEMPORARILY PROTECTS MINOR: - CUTS - SCRAPES - BURNS - TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND LIPS - HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER

Authorization status:

OTC monograph final

Summary of Product characteristics

REXALL PETROLEUM WITH VITAMIN E AND ALOE- PETROLATUM JELLY
DOLGENCORP INC
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
PETROLATUM 99.8%
PURPOSE
SKIN PROTECTANT
USE
TEMPORARILY PROTECTS MINOR:
CUTS
SCRAPES
BURNS
TEMPORARILY PROTECTS AND HELPS RELIEVE CHAPPED OR CRACKED SKIN AND
LIPS
HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
DO NOT GET INTO EYES
STOP USE AND ASK A DOCTOR IF
CONDITIONS LASTS MORE THAN 7 DAYS
_DO NOT USE ON_
DEEP PUNCTURE WOUNDS
ANIMAL BITES
SERIOUS BURNS
KEEP OUT OF REACH OF CHIDREN
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT
AWAY
DIRECTIONS
APPLY AS NEEDED
INACTIVE INGREDIENTS
ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE
LABEL COPY
REXALL PETROLEUM WITH VITAMIN E AND ALOE
petrolatum jelly
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:559 10 -316
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 .8 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:559 10 -316 -13
36 8 g in 1 JAR
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 3/0 3/20 15
LABELER -
DOLGENCORP INC (068331990)
REGISTRANT -
APOLLO HEALT H AND BEAUT Y CARE (201901209)
DOLGENCORP INC
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
APOLLO HEALTH AND BEAUTY CARE
20 19 0 120 9
ma nufa c ture (559 10 -316 )
Revised: 3/2015