HAND SANITIZER- alcohol spray 
FIFTEEN DEGREES co.,ltd

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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Hand Sanitizer Fifteen Degrees 80% alcohol

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Topical Antimicrobial

Purpose

Topical Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

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

Stop use and ask a doctor if irritation or rash appears and lasts.

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, glycerin, citrus limon (lemon) peel oil, limonene, citral

Package Label - Principal Display Panel

120 mL NDC: 74753-784-12

250 mL NDC: 74753-784-25

250ml

120ml

HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74753-784
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL) 0.0323 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 18.45 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP) 0.0017 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74753-784-12120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
2NDC:74753-784-25250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - FIFTEEN DEGREES co.,ltd (694982014)
Registrant - FARMER'S GRAIN KOREA LTD (694439983)

Revised: 1/2021
Document Id: b87939c5-7d5e-4615-e053-2a95a90af8b5
Set id: a76cec46-e512-57af-e053-2995a90a9075
Version: 3
Effective Time: 20210109
 
FIFTEEN DEGREES co.,ltd