HAND SANITIZER- alcohol liquid 
Rebel Rebel Personal Care Corp.

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) (80%, 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. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 65%. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic (skin) cleanser to help reduce bacteria on skin.

Warnings

Keep out of reach of children. For external use only. Flammable. Keep away from flame and heat. When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If swallowed get medical help or contact poison control centre right away.

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

Rub thoroughly into hands for at least 30 seconds. Allow to dry. Supervise children to avoid swallowing. Store between 15-30°C (59-86°F).

Other information

Inactive ingredients

Non Active Ingredients: Purified Water, Aloe Barbadensis Extract, Glycerin, Polysorbate 20, Denatonium Benzoate, Fragrance.

Package Label - Principal Display Panel

60 mL NDC: 82092-001-01

60 ml French Lavender NDC 82092 001 0160 ml French Lavender NDC 82092 001 0160 mL NDC: 82092-002-01

60 ml Magnolia NDC 82092 002 01

60 ml Magnolia NDC 82092 002 01

60 mL NDC: 82092-003-01

60 ml Hawaiian Plumeria NDC 82092 003 0160 ml Hawaiian Plumeria NDC 82092 003 01

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82092-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82092-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2021
HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82092-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
2-ACETONAPHTHONE (UNII: 21D49LOP2T)  
ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
GERANIOL (UNII: L837108USY)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82092-003-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2021
HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82092-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
PIPERONAL (UNII: KE109YAK00)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
GERANYL ACETATE (UNII: 3W81YG7P9R)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
PENTADECALACTONE (UNII: OK17S3S98K)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82092-002-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/2021
Labeler - Rebel Rebel Personal Care Corp. (204273499)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Rebel Personal Care Corp.204273499manufacture(82092-001, 82092-002, 82092-003)

Revised: 1/2023
Document Id: f26b449a-8c15-44a1-e053-2a95a90a54ae
Set id: d16fc3da-5d5e-48f3-e053-2995a90a53d7
Version: 2
Effective Time: 20230116
 
Rebel Rebel Personal Care Corp.