NOVOSPRAY- alcohol spray 
KEY QUIMICA S.A. DE C.V.

----------

58345-200

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

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

Warnings

Flammable, keep away from fire or flame. For external use only.

Do not use

this product in or near the eyes.

Stop use if irritation or redness develop. if conditions persist for more than 72 hours, consult a doctor.

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, fragrance, glycereth-7 triacetate, alpha-tocopherol and denatonium benzoate.

Package Label - Principal Display Panel

Novospray

4000

500

960

1L label

NOVOSPRAY 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58345-200
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
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
GLYCERETH-7 TRIACETATE (UNII: S9W6Z48HUP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58345-200-0112 in 1 BOX03/30/202012/30/2023
1300 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:58345-200-0212 in 1 BOX03/30/202012/30/2023
2500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:58345-200-036 in 1 BOX03/30/202012/30/2023
3960 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:58345-200-044000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202012/30/2023
5NDC:58345-200-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202012/30/2023
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: 177d2660-ea94-a726-e063-6294a90af9dd
Set id: ac493223-089b-6c46-e053-2a95a90a9a96
Version: 6
Effective Time: 20240502
 
KEY QUIMICA S.A. DE C.V.