AQUAFIRE by LENCURA DIRECT, INC.

AQUAFIRE by

Drug Labeling and Warnings

AQUAFIRE by is a Otc medication manufactured, distributed, or labeled by LENCURA DIRECT, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AQUAFIRE- alcohol liquid 
LENCURA DIRECT, INC.

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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This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand sanitizer to help reduce bacterial on hands. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• on children less than 2 months of age
• on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

• Place enough product in your palm to cover hands. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110°F(43°C)

Inactive ingredients

Water(Aqua), Isopropyl Alcohol, Glycerin, Aloe Barbadensis Extract, Triethanolamine

Package Label - Principal Display Panel

20mL NDC: 77912-006-001

AQUAFIRE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77912-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77912-006-01	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/30/2020	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	09/01/2020

Labeler - LENCURA DIRECT, INC. (117519185)

Revised: 12/2020

Document Id: b7c991d1-bcc2-a14d-e053-2a95a90a6d80

34390-5

Set id: aaa39b0e-8d76-c503-e053-2995a90a9d00

Version: 2

Effective Time: 20201231