Aloe Barrier by Aurena Laboratories AB ALOE BARRIER SPRAY

Aloe Barrier by

Drug Labeling and Warnings

Aloe Barrier by is a Otc medication manufactured, distributed, or labeled by Aurena Laboratories AB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALOE BARRIER- petrolatum spray 
Aurena Laboratories AB

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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ALOE BARRIER SPRAY

Drug Facts

Active Ingredient

Petrolatum 36%

Purpose

Skin Protectant

Uses

• Temporarily protects minor
  -cuts
  -scrapes
  -burns.
• Temporarily protects and helps relieve chapped or cracked skin and lips. 
• Helps treat and prevent diaper rash.
• Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings

For external use only.

Do not use on

• deep or puncture wounds
• animal bites
• serious burns.

When using this product

• avoid spraying in eyes
• do not intentially inhale.

Stop use and ask a doctor if

condition last more than 7 days.

Keep out of reach of children.

If swallowed, get medical help or consult 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 a thin continuous coating as needed.

​For diaper rash:​

• Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
• Apply as needed, 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)

Inactive Ingredients

Aloe Barbedensis Leaf Extract, Bis-Diglyceryl Polyacyladipate-2, Hexamethyldisiloxane, MIneral Oil

PACKAGE LABEL DISPLAY

NDC: 11914-036-60

ALOE BARRIER SPRAY

3 PROTECT

CLEAR BARRIER SPRAY

• Skin Protectant
• CHG Comopatible
• Soothes Irritated Skin
• For Weepy, Denuded Skin
• Fragrance & Dye Free
• Easy to Remove
• For All Ages

with a Natural Botanical

• Shake Before Use
• Apply from Any Angle

Net Wt. 2.1 oz. (60g)

Made in Sweden

CONTAINS NO CFCS WHICH DEPLETE THE OZONE LAYER

ALOE BARRIER 
petrolatum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11914-036
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11914-036-60	60 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/15/2020	09/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/15/2020	09/30/2022

Labeler - Aurena Laboratories AB (355607748)

Registrant - Aurena Laboratories AB (355607748)

Establishment
Name	Address	ID/FEI	Business Operations
Aurena Laboratories AB		355607748	manufacture(11914-036)

Revised: 9/2022

Document Id: e90cc85d-b4c0-5eb0-e053-2995a90acdab

34390-5

Set id: 38b47ec9-86db-4227-aba6-f33eede79a77

Version: 2

Effective Time: 20220919