HAND SANITIZER- hand sanitizer gel 
1201258 Ontario 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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Alcorub Sanitizer

  1. Alcohol (ethanol)- USP (66.5%, volume/volume (v/v))
  2. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Alcohol 66.5% 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

Isopropyl alcohol 3.5%v/v, Carbomer 941, Glyceryl acrylated/acrylic acid copolymer, Lime Oil, PEG-40 Hydrogenated Castor Oil, Aloe Vera Juice, Triethanolamine, Purified Water

Package Label - Principal Display Panel

For all package size

Example of Plastic Bottle

20ML NDC: 80129-005-01

50ML NDC: 80129-005-02

60ML NDC: 80129-005-03

100ML NDC: 80129-005-04

250ML NDC: 80129-005-05

500ML NDC: 80129-005-06

1000ML NDC: 80129-005-07

2000ML NDC: 80129-005-08

3785ML NDC: 80129-005-09

5000ML NDC: 80129-005-10

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83254-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.3 g  in 100 mL
LIME OIL (UNII: UZH29XGA8G) 0.3 g  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.6 g  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) 3.5 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.75 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.55 g  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 mL
WATER (UNII: 059QF0KO0R) 100 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83254-005-0220 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
2NDC:83254-005-0550 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
3NDC:83254-005-0660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
4NDC:83254-005-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
5NDC:83254-005-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
6NDC:83254-005-50500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
7NDC:83254-005-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
8NDC:83254-005-202000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
9NDC:83254-005-373785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
10NDC:83254-005-555000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2023
11NDC:83254-005-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
12NDC:83254-005-36360 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/24/2020
Labeler - 1201258 Ontario Inc. (256906595)
Registrant - 1201258 Ontario Inc. (256906595)
Establishment
NameAddressID/FEIBusiness Operations
1201258 Ontario Inc.256906595manufacture(83254-005) , pack(83254-005) , label(83254-005)

Revised: 7/2023
Document Id: 0077ade4-c56b-a58f-e063-6394a90a8f3e
Set id: f432ae74-2389-e5ad-e053-2a95a90a5c5b
Version: 5
Effective Time: 20230714
 
1201258 Ontario Inc.