FDA.reportPublic FDA data

HUSH Fast Acting Topical Anesthetic Gel

Manufacturer
Hush Anesthetic | Filltech USA, LLC
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:57:16

Label at a glance#

ProductHUSH Fast Acting Topical Anesthetic
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of discomfort and pain associated with minor burns and skin irritations minor cuts and scrapes itching

Dosage and administration

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of discomfort and pain associated with

  • minor burns and skin irritations
  • minor cuts and scrapes
  • itching

Warnings:

WARNINGS SECTION

For external use only.

Avoid contact with eyes.


Do not use In large quantities, particularly over raw surfaces or blistered areas


Stop use and ask a doctor if

  • skin becomes irritated
  • condition worsens or symptoms last more than 7 days
  • symptoms clear up and reoccur within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

HUSH Fast Acting Topical Anesthetic Gel 2oz/60g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

l1l1l2l2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49947-90949947-909-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
COMFREY LEAFDG4F8T839XIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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
982faa74-d481-cd1e-e053-2995a90afa1e2bf398a5-d4c0-4d1f-b3b6-2c583bfe79cc2019-11-25WarningsExact identifier
spl id: 982faa74-d481-cd1e-e053-2995a90afa1e
spl set id: 2bf398a5-d4c0-4d1f-b3b6-2c583bfe79cc

Reported adverse events (FAERS/openFDA)#

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