CALIDAD PREMIUM FRESH ANTIBACTERIAL- alcohol gel 
Distribuidora de Sistemas Didacticos , 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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Calidad Premium Fresh Gel Antibacterial

DRUG FACTS

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

INACTIVE INGREDIENTS

Distilled Water, Glycerin, Carbomer, Triethanolamine, EDTA, Without fragrance.

USE[S]

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

  • IN CHILDREN LESS THAN 2 MONTHS OF AGE
  • ON OPEN SKIN WOUNDS

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.

DIRECTIONS

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

Questions or Comments:

52 (55) 3686-0416 / 52 (55) 4741-7431 direccion@distribuidoradesistemas.com.mx

Package Labeling:

Label

CALIDAD PREMIUM FRESH ANTIBACTERIAL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79728-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETIC ACID (UNII: 9G34HU7RV0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79728-000-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/29/2020
Labeler - Distribuidora de Sistemas Didacticos , S.A. de C.V. (589811236)

Revised: 9/2022
Document Id: e8a32e53-3f64-5340-e053-2a95a90ad7af
Set id: 8a7f386f-7ceb-403f-bf61-69a0c8e204f1
Version: 2
Effective Time: 20220914
 
Distribuidora de Sistemas Didacticos , S.A. de C.V.