TRADEMARK HAND SANITIZER- alcohol gel 
Organikisimo, S.A. de C:V.

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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TRADEMARK HAND SANITIZER Alcohol 70%

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

For sanitizing to help reduce bacteria on the skin that potentially can cause disease.

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.


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

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, Carbomer, Glycerin,Triethanolamine, Tocopheryl Acetate (Vitamin E).

Package Label - TRADEMARK
59 ml NDC:79337-172-01

59 ml NDC:79337-172-01

TRADEMARK_59ml

Package Label - TRADEMARK
250 ml NDC:79337-172-02

250 ml NDC: 79337-172-02

TRADEMARK_250ml

Package Label - TRADEMARK
1000 ml NDC:79337-172-03

1000 ml NDC: 79337-172-03

TRADEMARK_1000ml

Package Label - TRADEMARK
3785 ml NDC: 79337-172-04

3785 ml NDC: 79337-172-04

TRADEMARK_3700ml

TRADEMARK HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79337-172
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
TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.3 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F) 0.6 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.15 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79337-172-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
2NDC:79337-172-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
3NDC:79337-172-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
4NDC:79337-172-043785 mL in 1 CONTAINER; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/19/2020
Labeler - Organikisimo, S.A. de C:V. (951579669)
Registrant - Organikisimo, S.A. de C:V. (951579669)
Establishment
NameAddressID/FEIBusiness Operations
Organikisimo, S.A. de C:V.951579669manufacture(79337-172)

Revised: 11/2020
Document Id: b47a6112-77d4-12cd-e053-2a95a90a812d
Set id: b47a6112-77d2-12cd-e053-2a95a90a812d
Version: 1
Effective Time: 20201119
 
Organikisimo, S.A. de C:V.