HAND SANITIZER- isopropyl alcohol gel 
Lokahi Brewing Company 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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Hand Sanitizer

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients.

  1. Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerin (4% v/v).
  3. Hydroxyethylcellulose (1.5% v/v).
  4. Aloe Barbadensis Leaf Juice (0.5% v/v).
  5. Sterile distilled water or boiled cold water.

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)

Isopropyl Alcohol 70% 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

glycerin, hydroxyethyl cellulose, Aloa Barbadensis, purified water USP

Package Label - Principal Display Panel

60 ml NDC: 78240-001-01

Label

HAND SANITIZER 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78240-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL42 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ) 0.3 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2.4 mL  in 100 mL
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) 0.9 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 24 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78240-001-0260 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 - Lokahi Brewing Company LLC (122458275)
Establishment
NameAddressID/FEIBusiness Operations
Lokahi Brewing Company LLC122458275manufacture(78240-001)

Revised: 6/2020
Document Id: a9d49f3c-f7df-ec81-e053-2995a90ade01
Set id: a9e8ef10-d013-b416-e053-2a95a90a77f8
Version: 4
Effective Time: 20200619
 
Lokahi Brewing Company LLC