CYBER CLEAN POWER GEL- hand sanitizer liquid 
JOKER AG

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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Cyber Clean Power gel

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. Water
  3. Carbomer Homopolymer
  4. Glycerin
  5. Aloe Vera Leaf
  6. Propylene Glycol
  7. Tert-butyl alcohol
  8. Denatonium benzoate
  9. Triisopropanolamine
  10. 3,5,5-TRIMETHYLHEXANAL

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)

Alcohol 72% 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

Water
Carbomer Homopolymer
Glycerin
Aloe Vera Leaf
Propylene Glycol
Tert-butyl alcohol
Denatonium benzoate
Triisopropanolamine
3,5,5-TRIMETHYLHEXANAL

Package Label - Principal Display Panel

123

CYBER CLEAN POWER GEL 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75757-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
3,5,5-TRIMETHYLHEXANAL (UNII: U62H30BXPJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75757-201-0120 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2020
2NDC:75757-201-0230 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2020
3NDC:75757-201-0450 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2020
4NDC:75757-201-055000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:75757-201-0340 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2020
6NDC:75757-201-0610000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:75757-201-0715000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - JOKER AG (480850932)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Berfly Cosmetic Co., Ltd553098664manufacture(75757-201)

Revised: 1/2021
Document Id: b9c7dbd3-aa67-262d-e053-2a95a90aedad
Set id: a537be9f-8c2b-694d-e053-2995a90a85c5
Version: 2
Effective Time: 20210126
 
JOKER AG