ALOE VESTA- petrolatum spray
Medline Industries, LP

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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772 Aloe Vesta Clear Barrier Spray

Active ingredient

White petrolatum 36% w/w

Purpose

Skin protectant

Uses

temporarily protects minor cuts, scrapes, and burns
temporarily protects and helps relieve chapped or cracked skin
helps treat and prevent diaper rash
protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

For external use only. Flammable; keep away from heat or flame

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

avoid spraying in eyes
do not intentionally inhale
do not puncture or incinerate; contents under pressure

Stop using and see a doctor if

condition worsens
symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

do not overspray
shake before use
hold can 4-6 inches from skin and spray

For skin protection

apply as needed

For Diaper rash

change wet and soiled diapers promptly, cleanse the diaper area and allow to dry
apply product liberally as often as necessary with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

store at 15°C-30°C (59°F-86°F)
for infants/neonates, please use under medical supervision

Inactive ingredients

aloe barbadensis leaf extract, bis-diglyceryl polyacyladipate-2, hexamethyldisiloxane, mineral oil

Manufacturing Information

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in Sweden of foreign and domestic materials

www.medline.com

1-800-MEDLINE

REF: 413401

V1RE21AUE

Package Label

Package label

ALOE VESTA
petrolatum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-772
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	36 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-772-14	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2021	03/04/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/01/2021	03/04/2024

Labeler - Medline Industries, LP (025460908)

Revised: 9/2022

Document Id: e90cb960-fa44-2822-e053-2a95a90a3ad0

Set id: af5f4221-8376-bcf3-e053-2a95a90ad3aa

Version: 5

Effective Time: 20220919

Medline Industries, LP