HAND SANITIZER- alcohol gel 
SOLARNA, 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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HAND SANITIZER GEL

DIRECTIONS AND USAGE

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

INACTIVE INGREDIENTS

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

Children under 6 years of age should be supervised when using.

Store below 110°F (43°C)

WARNINGS

Warnings

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

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

DOSAGE AND ADMINISTRATION

Place enough product on hands to cover all surfaces. Rub hands together until dry

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

HAND SANITIZER PACKAGE LABELS

LABEL 250 mL english JPG2LABEL 500 mL jpg englishLABEL 1000 mL JPG englishLABEL 4000 mL FINAL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78767-4001
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
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78767-4001-2250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
2NDC:78767-4001-3500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
3NDC:78767-4001-41000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
4NDC:78767-4001-54000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/05/2020
Labeler - SOLARNA, S.A. DE C.V. (951578903)
Registrant - SOLARNA, S.A. DE C.V. (951578903)
Establishment
NameAddressID/FEIBusiness Operations
SOLARNA, S.A. DE C.V.951578903manufacture(78767-4001)

Revised: 6/2020
Document Id: a750fd79-79b0-8778-e053-2a95a90aaac4
Set id: a750fd79-79af-8778-e053-2a95a90aaac4
Version: 1
Effective Time: 20200605
 
SOLARNA, S.A. DE C.V.