NOVOGEL- alcohol gel 
KEY QUIMICA S.A. DE C.V.

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58345-100

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Uses

To decrease bacteria on skin that could cause diseases. Recommended for reapeted use.

Warnings

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

Do not use

this product in or near the eyes.

Stop use if irritation or redness develop. If condition persists for more than 72 hours, consult a doctoer.

Keep out of reach of children. If swallowed, seek immediate medical attention or call a poison control center.

Directions

  • wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water (aqua), glycerin, carbomer, triethanolamine, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate.

Package Label - Principal Display Panel

Novogel

Novogel X4

Novogel UX

NOVOGEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58345-100
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
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58345-100-013 in 1 BOX03/30/202012/30/2023
11000 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58345-100-026 in 1 BOX03/30/202012/30/2023
2960 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58345-100-034 in 1 BOX03/30/202012/30/2023
34000 mL in 1 JUG; Type 0: Not a Combination Product
4NDC:58345-100-043 in 1 BOX03/30/202012/30/2023
44000 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)03/30/202012/30/2023
Labeler - KEY QUIMICA S.A. DE C.V. (810740548)

Revised: 5/2024
Document Id: 177d1d8c-4f60-a0fd-e063-6294a90a086f
Set id: ac3a1009-1646-57ce-e053-2995a90a6fcb
Version: 5
Effective Time: 20240502
 
KEY QUIMICA S.A. DE C.V.