SaniGuard-SF
- Manufacturer
- Inopak. Ltd
- Effective date
- 2022-06-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-05-31 23:50:03
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Alcohol 70% v/v
OTC - PURPOSE SECTION
Purpose
Antiseptic
INDICATIONS & USAGE SECTION
Uses
- to decrease bacteria on the skin after changing diapers, assisting ill persons or before contact with a person under medical care or treatment
- Recommended for repeated use
WARNINGS SECTION
Warnings
For external use only.
FLAMMABLE, keep away from heat or flames.
OTC - WHEN USING SECTION
When using this product keep away from eyes. In case of eye contact, flush eyes with water.
OTC - STOP USE SECTION
Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, contact a physician or poison control center.
DOSAGE & ADMINISTRATION SECTION
Directions
- apply liberally to hands to cover all surfaces.
- rub hands together until dry.
- supervise children under 6 years old.
- not recommended for infants.
INACTIVE INGREDIENT SECTION
Inactive ingredients Water, PEG-10 Dimethicone, Glycerin, Isopropyl Myristate, Polyquaternium-11, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate
SPL UNCLASSIFIED SECTION
Manufacturd for
Inopak, LTD. Ringwood, NJ 07456 • 1-800-762-7725 •
www.inopak.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SaniGuard SF
foam hand sanitizer
alcohol 70%
Compliant with CDC Hand Hygiene Guidlines
Does not contain DEA/MEA, triclosan, parabens, formaldehyde, dyes, fragrance
NET CONTENTS: 33.8 FL. OZ. (1000 ML)
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58575-150-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-12 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-18 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-37 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-42 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
| 58575-150-80 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3791-111a-e063-dadaa90a10e2 | Inopak SaniGuard-SF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58575-150-01 | SaniGuard-SF | 1000 mL in 1 POUCH | LIQUID | 1000 | 6 | |
| 58575-150-02 | SaniGuard-SF | 60 mL in 1 BOTTLE | LIQUID | 60 | 6 | |
| 58575-150-03 | SaniGuard-SF | 50 mL in 1 BOTTLE | LIQUID | 50 | 6 | |
| 58575-150-10 | SaniGuard-SF | 1000 mL in 1 BAG | LIQUID | 1000 | 6 | |
| 58575-150-12 | SaniGuard-SF | 1250 mL in 1 BAG | LIQUID | 1250 | 6 | |
| 58575-150-18 | SaniGuard-SF | 540 mL in 1 BOTTLE | LIQUID | 540 | 6 | |
| 58575-150-37 | SaniGuard-SF | 3840 mL in 1 BAG | LIQUID | 3840 | 6 | |
| 58575-150-42 | SaniGuard-SF | 3800 mL in 1 BOTTLE | LIQUID | 3800 | 6 | |
| 58575-150-80 | SaniGuard-SF | 800 mL in 1 BOTTLE | LIQUID | 800 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALCOHOL | ACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALCOHOL | ACTIVE MOIETY | 3K9958V90M | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| CHLORHEXIDINE GLUCONATE | INACTIVE INGREDIENT | MOR84MUD8E | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| PEG-10 DIMETHICONE (600 CST) | INACTIVE INGREDIENT | 8PR7V1SVM0 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYETHYLENE GLYCOL 600000 | INACTIVE INGREDIENT | 2126FD486L | 1 | |
| POLYQUATERNIUM-10 (30000 MPA.S AT 2%) | INACTIVE INGREDIENT | C7RDC8Y4JS | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- SaniGuard-SF
- ALCOHOL
- EDETATE DISODIUM
- ALPHA-TOCOPHEROL ACETATE
- ISOPROPYL MYRISTATE
- PEG-10 DIMETHICONE (600 CST)
- ALOE VERA LEAF
- POLYQUATERNIUM-11 (1000000 MW)
- WATER
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58575-150 | 58575-150-02, 58575-150-80, 58575-150-10, 58575-150-12, 58575-150-37, 58575-150-18, 58575-150-03, 58575-150-01, 58575-150-42 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ALPHA-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| PEG-10 DIMETHICONE (600 CST) | 8PR7V1SVM0 | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| POLYQUATERNIUM-11 (1000000 MW) | 0B44BS5IJS | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION / OPHTHALMIC | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SHAMPOO / TOPICAL | 0.2 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / TOPICAL | 0.02 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY, METERED / NASAL | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / AURICULAR (OTIC) | 0.01 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / TOPICAL | NA | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / AURICULAR (OTIC) | 0 %w/v | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | OINTMENT / TOPICAL | 0.03 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / OPHTHALMIC | 0.02 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / NASAL | 40.46 mg/100ml | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.02 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SWAB / TOPICAL | 43.9 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / RESPIRATORY (INHALATION) | 0.02 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRALESIONAL | 1 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRAMUSCULAR | 1 mg | ||
| POLYETHYLENE GLYCOL 600000 | POLYETHYLENE OXIDE 600000 | 2126FD486L | TABLET, EXTENDED RELEASE / ORAL | 189 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / TOPICAL | 72 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LIQUID / NASAL | 0.2 mg/1ml | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | GEL / OPHTHALMIC | 0.01 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | CLOTH / TOPICAL | NA | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | LOTION / TOPICAL | 0.1 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION / OPHTHALMIC | 2 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SPONGE / TOPICAL | 4 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SPRAY / NASAL | 1 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | OIL / AURICULAR (OTIC) | 6 mg | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | INJECTION / INTRA-ARTICULAR | 1 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg |
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 |
|---|---|---|---|---|---|---|
| e2ae02d1-6f7e-4192-e053-2a95a90aa3be | f05b8a05-1eb8-4734-90e0-9948e685854c | 2022-06-30 | Warnings | e2ae02d1-6f7e-4192-e053-2a95a90aa3be f05b8a05-1eb8-4734-90e0-9948e685854c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
