FDA.reportPublic FDA data

Refill 3

Manufacturer
CMC Group Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:52:36

Label at a glance#

ProductRefill 3
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Dosage and administration

Clean the affected area Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily Children under 2 years of age: consult a doctor May be covered with a sterile bandage

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Pain relieving cream

Uses

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• in the eyes  • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin monostearate, glycerol, purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn treatmentBurn treatment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN8
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD8
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49687-0017-0Refill 30.9 g in 1 PACKAGECREAM0.98
49687-0017-0Refill 310 in 1 BOXCREAM108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49687-0017REFILL 3 (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [CMC GROUP INC.]8Current NDC, Legacy NDC, 2 package rows20250115_e5cb395f-5037-4b0e-9c9d-2d78b5b01b25.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49687-001749687-0017-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
ndc (package): 49687-0017-0
ndc (product): 49687-0017
ndc11 (package): 49687001700
spl id: 2b9cfd46-fb22-a682-e063-6394a90a6ba3
spl set id: e5cb395f-5037-4b0e-9c9d-2d78b5b01b25

Reported adverse events (FAERS/openFDA)#

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