BARRIER CREAM- zinc oxide cream

Barrier Cream by

Drug Labeling and Warnings

Barrier Cream by is a Otc medication manufactured, distributed, or labeled by Avasol LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide (Non-nano) 10%

Purpose

Skin protectant

Uses

• Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
• Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Warnings

• For external use only
• Avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor

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

Do not use:

• if allergic to ingredients.
• on deep or puncture wounds
• on animal bites on serious burns.
• Test small area first.

Keep out of reach of children.

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

Directions

Apply liberally, directly on skin as needed. May be applied to prosthetics, protective equipment, etc. Will solidify at cold temps. Warm and knead as required.

Inactive ingredients

*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic **Wildcrafted

Other information

Protect from freezing. Avoid excessive heat.

Questions?

Call 888-805-1507 or visit www.avasol.com

Principal Display Panel - 59 mL Pouch Label

avasol®

BARRIER
CREAM

BIOBASED

Multipurpose

Anti-chafing

Skin protectant

No Petrochemicals No Synthetics

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

BARRIER CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58518-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ORANGE PEEL WAX (UNII: 0U715N387C)
ASTAXANTHIN (UNII: 8XPW32PR7I)
BENTONITE (UNII: A3N5ZCN45C)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY (UNII: IJ67X351P9)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
ST. JOHN'S WORT (UNII: UFH8805FKA)
CHAMOMILE (UNII: FGL3685T2X)
LICORICE (UNII: 61ZBX54883)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MANUKA OIL (UNII: M6QU9ZUH2X)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58518-040-02	59 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2022
2	NDC: 58518-040-03	28 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2022

Labeler - Avasol LLC (078822898)

Establishment
Name	Address	ID/FEI	Business Operations
Avasol LLC		078822898	MANUFACTURE(58518-040)