AQUAFIRE- alcohol liquid

AQUAFIRE by

Drug Labeling and Warnings

AQUAFIRE by is a Otc medication manufactured, distributed, or labeled by SHERLEKAR AIRCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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

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

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

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, Aloe Barbadensis Extract, Triethanolamine

Package Label - Principal Display Panel

5 L NDC: 78931-002-01

INGREDIENTS AND APPEARANCE

AQUAFIRE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78931-002
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)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78931-002-01	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

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

Labeler - SHERLEKAR AIRCARE PRIVATE LIMITED (861721920)

Establishment
Name	Address	ID/FEI	Business Operations
SHERLEKAR AIRCARE PRIVATE LIMITED		861721920	manufacture(78931-002)