ALFLEXIL ZERO PAIN

Manufacturer
CHEMCO CORPORATION
Effective date
2023-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:54

Label at a glance#

ProductALFLEXIL ZERO PAIN
Active ingredientLIDOCAINE HYDROCHLORIDE, CAMPHOR (SYNTHETIC), MENTHOL
Label structure13 sections

Dosage and administration

Adults and Children over 12 years of age: Apply a small amount on the area to be. Massaged in a circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age; do not use, consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.5%

Lidocaine 4%

Menthol 1%

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS SECTION

For external use only. · Ask a doctor before use if you have redness over affected area.

OTC - WHEN USING SECTION

Use only as directed
Do not bandage tightly or use with a heating pad.
Avoid contact with eyes and mucous membranes.
Do not apply to wounds or damaged, broken or irritated skin.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
If you experience an allergic reaction, discontinue use and consult a physician.

Do not expose the area treated with product to heat or direct sunlight.

OTC - STOP USE SECTION

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast – feeding

Ask a health professional before use.

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

Adults and Children over 12 years of age:

Apply a small amount on the area to be.
Massaged in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age; do not use, consult a doctor.

OTHER SAFETY INFORMATION

Other information

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat, Arnica Montana Flower Extract, Ceteareth-20, Propylene Glycol, Triethanolamine, Carbomer, Glycerin, Methyl Salicylate, Sodium Chondroitin Sulfate, Disodium EDTA, Glucosamine Sulfate, Tocopheryl Acetate, Rosmarinus Officinalis (Rosemary) Extract, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Blue No.1 (CI 42090).

OTC - QUESTIONS SECTION

+1(305)597-6410

ALFLEXIL ZERO PAIN ROLL-ON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALFLEXIL ZERO PAINALFLEXIL ZERO PAIN

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49283-145-03ALFLEXIL ZERO PAIN90 g in 1 BOTTLE, WITH APPLICATORGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49283-145ALFLEXIL ZERO PAIN (CAMPHOR, LIDOCAINE HCL, MENTHOL) GEL [CHEMCO CORPORATION]11 package rows20231019_05574935-31b8-1c4a-e063-6394a90a82cb.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49283-14549283-145-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
05574941-6443-c7ad-e063-6394a90a698605574935-31b8-1c4a-e063-6394a90a82cb2023-09-14WarningsExact identifier
spl id: 05574941-6443-c7ad-e063-6394a90a6986
spl set id: 05574935-31b8-1c4a-e063-6394a90a82cb

Reported adverse events (FAERS/openFDA)#

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