Indications and uses
to decrease bacteria on the skin that could cause disease recommended for repeated use
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
Dosage and administration
wet hands thoroughly with product and allow to dry without wiping for children under 6, ues only under adult supervision not recommended for infants
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient:
Ethyl alcohol 62%
Purpose
Antiseptic
Uses
- to decrease bacteria on the skin that could cause disease
- recommended for repeated use
Warnings
For external use only: hands
Flammable. Keep away from heat and flame.
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
Stop use and ask a doctor if
- irritation or redness develops
- condition persists for more that 72 hours
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.
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
Other Information
- do not store above 105F
- may discolor some fabrics
- harmful to wood finishes and plastics
Inactive ingredients
acrylates/C10-C30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, glycerin, maltodextrin, propylene glycol, triethanolamine, water
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71927-001-02 | 2025-04-07 | C162847 | 48780-1 | 2cef2736-86fe-d83d-e063-dadaa90ab31f | 71927-001 |
| 71927-001-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-86fe-d83d-e063-dadaa90ab31f | 71927-001 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71927-001-02 | 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
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- TROLAMINE
- ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71927-001 | 71927-001-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
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 | aa846bb7-a64b-3358-e053-2995a90a9d09 | 2025-04-07 | Warnings | 71927-001-02 71927-001 71927000102 3239e5cb-62d5-8f7c-e063-6294a90a336b aa846bb7-a64b-3358-e053-2995a90a9d09 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.