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Hand sanitizer - Medication Information

Product NDC Code 58037-102
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 62 ml/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581660
Application Number part333A
Labeler Name Pride Products Corp.
Packages
Package NDC Code Description
58037-102-11 236 ml in 1 bottle (58037-102-11)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT ETHYL ALCOHOL 62.0%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DIRECTIONS WET HANDS THOROUGHLY WITH PRODUCT AND RUB INTO SKIN UNTIL DRY. CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED BY AN ADULT WHEN USING THIS PRODUCT.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS WATER (AQUA), ALOE BARBADENSIS LEAF JUICE, CARBOMER, FRAGRANCE, GLYCERIN, PROPYLENE GLYCOL, TOCOPHERYL ACETATE (VITAMIN E), TRIETHANOLAMINE, FD&C BLUE NO. 1, FD&C YELLOW NO. 5.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
USES HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

Purpose

Information about the drug product’s indications for use.
PURPOSE ANTIMICROBIAL

Spl product data elements

Usually a list of ingredients in a drug product.
HAND SANITIZER ETHYL ALCOHOL ALOE VERA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 ALCOHOL ALCOHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
01b LBL_Hand Sanitizer_8oz

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS FOR EXTERNAL USE ONLY FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME. WHEN USING THIS PRODUCT AVOID CONTACT WITH FACE, EYES, AND BROKEN SKIN. IN CASE OF EYE CONTACT, FLUSH WITH PLENTY OF WATER AND SEEK MEDICAL ADVICE. STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API