ALOE VERA PETROLATUM JELLY- petrolatum jelly
ASTONEA LABS PRIVATE LIMITED

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Aloe Vera Petroleum Jelly

Active Ingredient

White Petrolatum (99.35% 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

Aloe vera extract, Vitamin E , Fragrance

Package Label

Principal Display and Drug Fact Panel

ALOE VERA PETROLATUM JELLY
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77338-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.35 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:77338-103-05	368 g in 1 JAR; Type 0: Not a Combination Product	07/01/2023
2	NDC:77338-103-03	226 g in 1 JAR; Type 0: Not a Combination Product	06/12/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/12/2023

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024

Document Id: 1bbaa2b3-9325-9aab-e063-6394a90a14c9

Set id: ffe98086-b5c3-4731-e053-6394a90a28dc

Version: 2

Effective Time: 20240625

ASTONEA LABS PRIVATE LIMITED