Ultilet Instant Hand Sanitizer Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Boca Med LLC dba Boca Medical Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Boca Med LLC dba Boca Medical Products

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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Ultilet Instant Hand Sanitizer Gel

Active Ingredient(s)

Ethanol Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

• in 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 between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
• May dissolve certain fabrics or surfaces

Inactive ingredients

water, glycerin, carbomer, ammomethyl propanol

Package Label - Principal Display Panel

30 mL NDC: 8326-6411-01

50 mL NDC: 8326-6411-17

100 mL NDC: 8326-6411-34

300 mL NDC: 8326-6411-10

500 mL NDC: 8326-6411-16

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 8326-6411
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.15 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 8326-6411-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 8326-6411-17	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 8326-6411-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 8326-6411-10	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 8326-6411-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020	01/31/2023

Labeler - Boca Med LLC dba Boca Medical Products (121164730)

Revised: 7/2021

Document Id: c7197070-541a-4d15-e053-2995a90a29ce

34390-5

Set id: a616352e-cc9f-19a8-e053-2995a90adc5d

Version: 2

Effective Time: 20210714