Dr. Cliffs Instant Hand Sanitizer by Florida Rum Company LLC

Drug Details [pdf]

DR. CLIFFS INSTANT HAND SANITIZER WITH VITAMIN E- alcohol gel
Florida Rum Company LLC

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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.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Purified water.

Different or additional ingredients may impact the quality and potency of the product.*

*Carbomer, fragrance, and Vitamin E Acetate have been added to improve aroma and texture.

Active Ingredient(s)

Ethyl 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)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP, carbomer, fragrance, tocopherol acetate

Package Label - Principal Display Panel

Principal Display Label

DR. CLIFFS INSTANT HAND SANITIZER WITH VITAMIN E
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74257-204
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	4 mL in 100 mL
2-ETHYLHEXANOL (UNII: XZV7TAA77P)	0.5 mL in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.5 mL in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.25 g in 100 mL
PHENYLMERCURIC NITRATE (UNII: CG8692ZN14)	0.5 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 74257-204-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	09/01/2020	12/31/2020

Labeler - Florida Rum Company LLC (085456921)

Revised: 12/2024

Document Id: 28b35c0d-d5fa-d924-e063-6394a90a5747

Set id: afd6af4b-f964-3898-e053-2995a90a8aae

Version: 2

Effective Time: 20241207