FDA.reportPublic FDA data

SafetyMax Sanitizer Gel

Manufacturer
SafetyMax Corporation | Fujian Jinghua Blotechnology Co., Ltd.
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:19:48

Label at a glance#

ProductSafety Max
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and allow to dry without whipping. For children under 6 years use only under adult supervision. Not recommended for infants.

Storage and handling

Store below 106 F (41 C) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable. Keep away from heat or flame.

For external use only-Hands.

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

  • Wet hands thoroughly with product and allow to dry without whipping.
  • For children under 6 years use only under adult supervision.
  • Not recommended for infants.

Other information

STORAGE AND HANDLING SECTION

  • Store below 106 F (41 C)
  • May discolor certain fabrics or surfaces.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbomer, sodium hydroxide, Ethylhexyl glycerin, Aloe barbadensis leaf extract

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 78503-111-03500 mL NDC: 78503-111-03

500 mL NDC: 78503-111-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78503-111-012022-01-28C16284748780-1d6a99b39-75c5-a426-e053-dadaa90af4c2SafetyMax Sanitizer Gel
78503-111-022022-01-28C16284748780-1d6a99b39-75c5-a426-e053-dadaa90af4c2SafetyMax Sanitizer Gel
78503-111-032022-01-28C16284748780-1d6a99b39-75c5-a426-e053-dadaa90af4c2SafetyMax Sanitizer Gel
78503-111-042022-01-28C16284748780-1d6a99b39-75c5-a426-e053-dadaa90af4c2SafetyMax Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78503-111-01Safety Max60 mL in 1 BOTTLEGEL602
78503-111-02Safety Max100 mL in 1 BOTTLEGEL1002
78503-111-03Safety Max500 mL in 1 BOTTLEGEL5002
78503-111-04Safety Max5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78503-111SAFETY MAX (DISINFECTANT GEL) GEL [SAFETYMAX CORPORATION]2Legacy NDC, 4 package rows20200702_a77a20df-075a-ef40-e053-2a95a90ab0e6.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78503-11178503-111-01, 78503-111-02, 78503-111-03, 78503-111-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GERANIOLL837108USYIACT
CITRALT7EU0O9VPPIACT
LINALOOL, (+)-F4VNO44C09IACT
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER 934Z135WT9208IACT
WATER059QF0KO0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZYL BENZOATEN863NB338GIACT
LIMONENE, (+)-GFD7C86Q1WIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
a9622e9c-1085-3b96-e053-2a95a90a9a4ca77a20df-075a-ef40-e053-2a95a90ab0e62020-07-01WarningsExact identifier
spl id: a9622e9c-1085-3b96-e053-2a95a90a9a4c
spl set id: a77a20df-075a-ef40-e053-2a95a90ab0e6

Reported adverse events (FAERS/openFDA)#

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