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

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.

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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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

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

Other information

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:74257-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENYLMERCURIC NITRATE (UNII: CG8692ZN14) 0.5 mL  in 100 mL
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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74257-204-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/2020
Labeler - Florida Rum Company LLC (085456921)

Revised: 9/2020
Document Id: afd6b34f-14d3-c6a0-e053-2995a90abf4b
Set id: afd6af4b-f964-3898-e053-2995a90a8aae
Version: 1
Effective Time: 20200921
 
Florida Rum Company LLC