HAND SANITIZER SET- alcohol gel 
Double Body Biotech Limited

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.

----------

Active ingredient

Alcohol 75%

Purpose

Antiseptic

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 heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

Wet hands thoroughly with gel, rub vigorously and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Other information

Store below 106 F(41 C)

Inactive ingredients

water

glycereth-26

aloe barbadensis extract,

carbomer,

sodium hydroxide,

may contain: red 33, red 4, yellow 5, blue 1, red 40.

Label

Label

Label

Label

Label

Label

Label

Label

Label

Label

Label

Label

Label

Label

HAND SANITIZER SET 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74657-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
GLYCERETH-26 (UNII: NNE56F2N14)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
ALOE (UNII: V5VD430YW9)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74657-004-0129.6 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Double Body Biotech Limited (560246954)
Establishment
NameAddressID/FEIBusiness Operations
Double Body Biotech Limited560246954manufacture(74657-004)

Revised: 8/2020
Document Id: ac086e51-eeaa-4aa5-e053-2a95a90a1154
Set id: a9d4d100-44e1-dd96-e053-2995a90a0a5e
Version: 2
Effective Time: 20200804
 
Double Body Biotech Limited