HAND SANITIZER- alcohol gel 
Ko-pack Inc

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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Monsoon Supply Company Hand Sanitizers

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

Flammable, keep away from fire or flame

For external use only.

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

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 redness develops.

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, Hydroxypropylcellulose, Water

Package Label - Principal Display Panel

59 mL NDC: 78948-648-02

Monsoon Supply Company - 2 fl oz size

473 mL NDC: 78948-648-16

Monsoon Supply Company - 16 fl oz size

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78948-648
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
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78948-648-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
2NDC:78948-648-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2020
Labeler - Ko-pack Inc (122354374)

Revised: 7/2020
Document Id: a97d917a-6b60-b9bd-e053-2a95a90afcce
Set id: a97da775-9034-62cb-e053-2995a90a8e6c
Version: 1
Effective Time: 20200702
 
Ko-pack Inc