OTC Medication Information: Antiseptic Hand Sanitizer

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.

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

  • do not store above 110°F (43°C)
  • may discolor certain fabrics, or may harm some wood finishes and plastics

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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Label4
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Package Labeling: (65055-600-02)

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ANTISEPTIC HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65055-600
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.62 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65055-600-00 60 mL in 1 BOTTLE None
2 NDC:65055-600-01 120 mL in 1 BOTTLE None
3 NDC:65055-600-02 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/24/2020
Labeler — Laboratorios Jaloma S.A. de C.V. (811122357)

Revised: 03/2020 Laboratorios Jaloma S.A. de C.V.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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