Hand Sanitizer

Manufacturer
Hemani International
Effective date
2024-06-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:59:55

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product (percentage in final product formulation):

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
  2. Sterile distilled water or boiled cold water.
  3. Glycerol (5% v/v).
  4. Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked)(1.5% v/v).
  5. Propylene Glycol (1% v/v).
  6. Fragrance (Dimethyl Anthranilate) (0.5% v/v).
  7. Triethanolamine (0.15% v/v).
  8. Dexpanthenol (Panthenol) (0.10% v/v).
  9. Aloe Barbadensis Leaf Juice Powder (0.05% v/v).
  10. Beads (Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260) (0.02% v/v).
  11. Blue 1 (CI 42090) (0.005% v/v).

The firm does not add other active or inactive ingredients besides listed above.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), glycerin (glycerol), Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked), propylene glycol, Fragrance (Dimethyl Anthranilate), Triethanolamine, Dexpanthenol (Panthenol), Aloe Barbadensis Leaf Juice Powder, Beads [(Mannitol, Microcrystalline Cellulose, Hydroxypropyl Methylcellulose, Pigment Green 7 (CI 74260)], Blue 1 (CI 42090)

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​50 mL NDC: 75360-1125-1

65 mL NDC: 75360-1125-2

100 mL NDC: 75360-1125-3

250 mL NDC: 75360-1125-4

1 L NDC: 75360-1125-5

500 mL NDC: 75360-1125-6

50 mL Label50 mL Label65 mL Label65 mL Label100 mL Label100 mL Label250 mL Label250 mL Label1L Label1L Label

500mL Label500mL Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75360-112575360-1125-1, 75360-1125-2, 75360-1125-4, 75360-1125-5, 75360-1125-3, 75360-1125-6, 75360-1125-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
288d0bff-3065-8c5c-e063-6394a90a2235a3bc102f-0403-8854-e053-2995a90ad0042024-12-05WarningsExact identifier
spl set id: a3bc102f-0403-8854-e053-2995a90ad004

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.