DICOLOR- 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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dicolor Hand Sanitizer Gel

DIRECTIONS DOSAGE AND ADMINISTRATION

Directions

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

INACTIVE INGREDIENTS

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

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.

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

Store below 110°F (43°C)

Avoid freezing and excessive heat above 40C (104F)

Supervise children under 6 years of age when using this product to avoid swallowing.

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

WARNINGS

Warnings

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

ACTIVE INGREDIENT

Active ingredient Ethyl Alcohol 70% v/v

ASK A DOCTOR

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PACKAGE LABELS

DI COLOR HAND SANITIZER GEL

DICOLOR 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79050-0040
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) 0.248 mL  in 1 mL
AMMONIA (UNII: 5138Q19F1X) 0.007 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.02 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.025 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79050-0040-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/17/2020
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(79050-0040)

Revised: 11/2020
Document Id: b3425f94-30a6-dc2b-e053-2995a90a7106
Set id: a7dc78e4-583c-9a9e-e053-2995a90a40c7
Version: 2
Effective Time: 20201104
 
SODI PINTURAS, S.A. DE C.V.