Hand Sanitizer
- Manufacturer
- Orazen Inc
- Effective date
- 2025-04-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:58:46
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient:
Ethyl alcohol 62%
OTC - PURPOSE SECTION
Purpose
Antiseptic
WARNINGS SECTION
Warnings
For external use only: hands
Flammable. Keep away from fire and flame.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- irritation or redness develops
- condition persists for more that 72 hours
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(1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- wet hands thoroughly with product and allow to dry without wiping
- for children under 6, ues only under adult supervision
- not recommended for infants
INACTIVE INGREDIENT SECTION
Inactive ingredients
acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water
OTHER SAFETY INFORMATION
Other Information
- do not store above 105F
- may discolor some fabrics
- harmful to wood finishes and plastics
INDICATIONS & USAGE SECTION
Uses to decrease bacteria on the skin that could cause disease. recommended for repeated use
OTC - WHEN USING SECTION
When using this product
- keep out of eyes. In case of contact with eyes, flush thoroughly with water.
- avoid contact with broken skin
- do not inhale or ingest
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71927-008-01 | 2025-04-07 | C162847 | 48780-1 | 2cef2736-9e37-d83d-e063-dadaa90ab31f | 71927-008 |
| 71927-008-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9e37-d83d-e063-dadaa90ab31f | 71927-008 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71927-008-01 | Hand Sanitizer | 30 mL in 1 BOTTLE, PLASTIC | GEL | 30 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ETHYL ALCOHOL
- MALTODEXTRIN
- ALOE VERA LEAF
- ALCOHOL
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71927-008 | 71927-008-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hand Sanitizer | ETHYL ALCOHOL | Orazen Inc | 9ae42862-f730-9d67-e053-2a95a90af955 | 2025-04-07 | Warnings | 71927-008-01 71927-008 71927000801 323a2253-01ae-de24-e063-6394a90ae0d7 9ae42862-f730-9d67-e053-2a95a90af955 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.