KORA DAILY SAFE 62- hand sanitizer gel gel 
Kora Holdings 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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Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic. Hand Sanitizer

Use

For hand sanitizer to reduct microorganisms that potentially can cause diseases. Recommended for repeated use.

Warnings

For external use on hands only. Flammable. Keep away from fire or flame.

Do not use

in or near the eyes.In case of contact with eyes, rinse eyes thoroughly with water.

When using this product do not use or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center immediately.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using.

Other information

Store below 110°F (43°C)

Inactive ingredients

Ethyl alcohol, Sterile Distilled water, Carbomer, Triethanolamine, Polyglyceryl-2-triisostearate, Dipropylene glycol, L-Menthol, Sodium Hyaluronate 1%, Lemon fragrance

500mL

NDC:75504-162-11

Daily Safe 62 Gel

KORA DAILY SAFE 62 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75504-162
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.3 mL  in 100 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 mL  in 100 mL
DIPROPYLENE GLYCOL (UNII: E107L85C40) 0.2 mL  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) 0.1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) 2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 34.8 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75504-162-11500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/27/2020
Labeler - Kora Holdings LLC (695692001)
Establishment
NameAddressID/FEIBusiness Operations
Sellus690026575manufacture(75504-162)

Revised: 12/2020
Document Id: b68b6e8a-a196-179d-e053-2a95a90ace87
Set id: a3db17b9-9544-ea0b-e053-2995a90aeac1
Version: 2
Effective Time: 20201215
 
Kora Holdings LLC