Aquafire: 2.0ml Sachet 30ml Tube, 50ml Tube, 75ml Tube, 100ml Tube 100ml bottle, 250ml bottle, 500ml bottle

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 gel 
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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Aquafire:
2.0ml Sachet
30ml Tube, 50ml Tube, 75ml Tube, 100ml Tube
100ml bottle, 250ml bottle, 500ml bottle

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 bacteria 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 on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store below 110F (43C)

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Tocopheryl Acetate, Acrylates / c-10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Extract, Triethanolamine

Package Label - Principal Display Panel

250mL NDC: 77912-005-01

2mL NDC: 77912-005-09

AQUAFIRE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77912-005
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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
CARBOMER 980 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77912-005-01	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	09/01/2020
2	NDC: 77912-005-02	1.2 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020	09/01/2020
3	NDC: 77912-005-03	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	09/01/2020
4	NDC: 77912-005-04	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020	09/01/2020
5	NDC: 77912-005-05	50 mL in 1 TUBE; Type 0: Not a Combination Product	03/30/2020	09/01/2020
6	NDC: 77912-005-09	2 mL in 1 PACKET; Type 0: Not a Combination Product	03/30/2020	09/01/2020
7	NDC: 77912-005-06	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/30/2020	09/01/2020
8	NDC: 77912-005-07	75 mL in 1 TUBE; Type 0: Not a Combination Product	03/30/2020	09/01/2020
9	NDC: 77912-005-08	100 mL in 1 TUBE; 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: b7c93e10-e84b-e776-e053-2995a90ae317

34390-5

Set id: a7e0951d-4f4a-3dd6-e053-2a95a90a3fb9

Version: 7

Effective Time: 20201231