FDA.reportPublic FDA data

Germiderm Hand Sanitizer

Manufacturer
REAL NUTRICION Y BELLEZA, S.A. de C.V
Effective date
2021-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:19:44

Label at a glance#

ProductGermiderm Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

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

Storage and handling

Store between 68F to 77F (20 TO 25C) do not expose to excessive heat TAMPER EVIDENT: Do not use if seal under cap is torn or missing.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Benzalkonium choloride 0.13% v/v..............................Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

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.

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 and 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 68F to 77F (20 TO 25C)
  • do not expose to excessive heat

TAMPER EVIDENT: Do not use if seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, benzyl alcohol, carbomer 940, ethylexylglycerin, fragrance, glycerin, trolamine, water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500 mL NDC: 78040-100-17

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78040-100-172023-09-25C16284748780-1f386c64a-4991-0266-e053-dadaa90a7c1aGermiderm Hand Sanitizer
78040-100-172023-01-30C16284748780-1f386c64a-4991-0266-e053-dadaa90a7c1aGermiderm Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78040-10078040-100-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT

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
06301102-983a-5cf8-e063-6294a90a20fea746c5b6-a932-4709-e053-2995a90af94d2023-01-01WarningsExact identifier
spl set id: a746c5b6-a932-4709-e053-2995a90af94d

Reported adverse events (FAERS/openFDA)#

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