ALCOHOL ANTISEPTIC TOPICAL SOLUTION- alcohol gel 
Healthy Foods & Nutrition Lab de México, 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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Alcohol Antiseptic Topical Solution

DRUG FACTS

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

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 mix use with other household chemicals.

Do not use

- In children less than two 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 maybe signs of serious condititon.

Keep out of reach of children.

If swallowed, get medical help or contact a poision control center right away.

Directions

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

Other information

- Store between 15-30C (59-86F)
- Avoid freezing and excesive heat above 40C (104F)

Inactive Ingredients

Purified water, glicerin, aloe vera extract, lavender scent, tocopheryl acetate (vitamin E).

Questions

011525553611180 8:00 AM - 5:00 PM (EAST)

Package Labeling:60 ML

Label

Package Labeling:125 ML

Label2

Package Labeling:3.78L

Label3

ALCOHOL ANTISEPTIC TOPICAL SOLUTION 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77740-000
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77740-000-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
2NDC:77740-000-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
3NDC:77740-000-023780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/07/2020
Labeler - Healthy Foods & Nutrition Lab de México, S.A. de C.V. (951577587)

Revised: 5/2020
Document Id: a691ba54-1a25-efc1-e053-2995a90a90af
Set id: a604e7a5-b361-3b36-e053-2995a90a0d97
Version: 2
Effective Time: 20200526
 
Healthy Foods & Nutrition Lab de México, S.A. de C.V.