ANTISEPTIC HAND SANITIZER- alcohol gel 
Laboratorios Jaloma 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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Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Ethyl alcohol 62%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only
Flammable, keep away from fire or flame.

Do not use 

in the eyes

Stop use and ask a doctor if

  • irritation and redness develop 
  • condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

wet hands thoroughly with product and allow to dry without wiping

Other information

Inactive ingredients

Water, glycerin, fragrance, tocopherol acetate, carbomer and triethanolamine.

Questions or comments?

+1 818 763 8698

Package Labeling: (65055-600-00)

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Package Labeling: (65055-600-01)

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Package Labeling: (65055-600-02)

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ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65055-600-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
2NDC:65055-600-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
3NDC:65055-600-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/24/2020
Labeler - Laboratorios Jaloma S.A. de C.V. (811122357)

Revised: 3/2020
Document Id: a1d96490-5c94-3472-e053-2995a90a96e6
Set id: 676355bc-139e-4c9d-9ee0-c31314fcb9a4
Version: 3
Effective Time: 20200327
 
Laboratorios Jaloma S.A. de C.V.