D Hand: Package Insert and Label Information

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.

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 mL
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LABEL 125 mL
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LABEL 250 mL
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LABEL 500 mL
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LABEL 1000 mL
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D HAND
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79050-0030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
TRIETHANOLAMINE CAPROYL GLUTAMATE 0.002 mL in 1 mL
CARBOMER 940 0.003 mL in 1 mL
WATER 0.293 mL in 1 mL
GLYCERIN 0.003 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79050-0030-1 60 mL in 1 BOTTLE None
2 NDC:79050-0030-2 125 mL in 1 BOTTLE None
3 NDC:79050-0030-3 250 mL in 1 BOTTLE None
4 NDC:79050-0030-4 500 mL in 1 BOTTLE None
5 NDC:79050-0030-5 1000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/04/2020
Labeler — SODI PINTURAS, S.A. DE C.V. (951579471)
Registrant — SODI PINTURAS, S.A. DE C.V. (951579471)
Establishment
Name Address ID/FEI Operations
SODI PINTURAS, S.A. DE C.V. 951579471 manufacture (79050-0030)

Revised: 08/2020 SODI PINTURAS, S.A. DE C.V.

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