AURA CACIA HAND SANITIZER TEA TREE CITRUS- alcohol solution

Aura Cacia Hand Sanitizer by

Drug Labeling and Warnings

Aura Cacia Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Frontier Co-op, Aura Cacia. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Alcohol 80% v/v

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• for hand washing to decrease bacteria on the skin
• recommended for repeated use

WARNINGS

Warnings

For external use only

Flammable. Keep away from fire or flame.

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develop or persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• wet hands thoroughly with product
• allow to dry without wiping
• supervise children under 6 years old
• not recommended for infants

STORAGE AND HANDLING

Other information

• Store between 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

Purified water USP, glycerin, tea tree oil, hydrogen peroxide, sweet orange oil, nutmeg oil, ylang ylang oil.

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DISTRIBUTED BY FRONTIER CO-OP

NORWAY, IA 52318 USA

1-800-669-3275

©2020 FRONTIER CO-OP

WWW.AURACACIA.COM

PRINCIPAL DISPLAY PANEL

AURA CACIA®

HAND SANITIZER

Non-sterile Solution

TEA TREE CITRUS

Alcohol Antiseptic 80% Topical Solution

Kills 99.9% of Common Germs

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

AURA CACIA HAND SANITIZER  TEA TREE CITRUS
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74246-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
NUTMEG OIL (UNII: Z1CLM48948)
ORANGE OIL (UNII: AKN3KSD11B)
CANANGA OIL (UNII: 8YOY78GNNX)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74246-103-02	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/11/2020	11/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/11/2020	11/12/2025

Labeler - Frontier Co-op (091387597)

Establishment
Name	Address	ID/FEI	Business Operations
Aura Cacia		088851855	manufacture(74246-103)