D HAND- alcohol gel 
SODI PINTURAS, 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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D HAND SANITIZER GEL

ACTIVE INGREDIENT

Active ingredient Ethyl Alcohol 70% v/v

PURPOSE

Purpose Antmicrobial

INDICATIONS AND USAGE

Use[s]

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

Directions

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

DOSAGE AND ADMINISTRATION

Directions

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.

WARNINGS AND PRECAUTIONS

Store below 110°F (43°C)

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

WARNINGS

Warnings

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

STOP USE

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

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

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Carbomer, Triethanolamine

PACKAGE LABELS

LABEL 60 mLLABEL 125 mLLABEL 250 mLLABEL 500 mLLABEL 1000 mL

D HAND 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79050-0030
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
CARBOMER 940 (UNII: 4Q93RCW27E) 0.003 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.293 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.003 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79050-0030-160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
2NDC:79050-0030-2125 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
3NDC:79050-0030-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
4NDC:79050-0030-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
5NDC:79050-0030-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/04/2020
Labeler - SODI PINTURAS, S.A. DE C.V. (951579471)
Registrant - SODI PINTURAS, S.A. DE C.V. (951579471)
Establishment
NameAddressID/FEIBusiness Operations
SODI PINTURAS, S.A. DE C.V.951579471manufacture(79050-0030)

Revised: 8/2020
Document Id: ac16f9f6-572e-24ec-e053-2a95a90ad1cc
Set id: ac16f9f6-572d-24ec-e053-2a95a90ad1cc
Version: 1
Effective Time: 20200804
 
SODI PINTURAS, S.A. DE C.V.