XENCARE INFLAMAX NATURAL TOPICAL PAIN

Manufacturer
Xenex Laboratories Inc.
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:56:47

Label at a glance#

ProductXENCARE INFLAMAX NATURAL TOPICAL PAIN
Active ingredientCAPSAICIN, LEVOMENTHOL
Label structure14 sections

Indications and uses

Formatting of the following sections were changed: Indications and Usage Dosage and Administration Contents remain the same as before. March 2025

Dosage and administration

Formatting of the following sections were changed: Indications and Usage Dosage and Administration Contents remain the same as before. March 2025

Storage and handling

Other Information Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient SectionActive Ingredient Section

Active Ingredients Purpose
Menthol 4% .................................................Topical Analgesic
Capsaicin 0.025% .........................................Topical Analgesic

INDICATIONS & USAGE SECTION

UsesUses

Uses
For the temporary relief of minor aches and
pains of muscles and joints associated
with:
• Arthritis • Simple backache • Sprains
• Bruises • Strains

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Directions
Adults and children 2 years of age and
older • Apply to affected area not more
than 3 to 4 times daily.
Children under 2 years of age • Do not
use, consult a physician.

STORAGE AND HANDLING SECTION

Storage sectionStorage section

Other Information

Store at room temperature.

INACTIVE INGREDIENT SECTION

InactiveInactive

Inactive Ingredients
Alcohol, Aloe Vera Leaf Extract, Ascorbyl
Palmitate, Caprylic/Capric Triglyceride,
Ceteareth-20, Cetearyl Alcohol, Cetyl
Alcohol, Coconut Oil, Diazolidinyl Urea,
Dimethicone, Edetate Disodium, Glycerin,
Glyceryl Stearate, Helianthus Annuus Seed
Wax, Iodopropynyl Butylcarbamate,
Isopropyl Myristate, Jojoba Esters,
Kawakawa Extract, Lecithin, Magnesium
Aluminum Silicate, Polyglycerin-3,
Safflower Oil, Sodium Stearoyl Glutamate,
Stearyl Alcohol, Turmeric Oil, Water,
Xanthan Gum.

OTC - WHEN USING SECTION

When UsingWhen Using

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

OTC - STOP USE SECTION

Stop UseStop Use

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Reach of ChildrenReach of Children

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

OTC - DO NOT USE SECTION

Do Not UseDo Not Use

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

OTC - PREGNANCY OR BREAST FEEDING SECTION

PregnancyPregnancy

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

OTC - PURPOSE SECTION

PurposePurpose

Uses
For the temporary relief of minor aches and
pains of muscles and joints associated
with:
• Arthritis • Simple backache • Sprains
• Bruises • Strains

WARNINGS SECTION

WarningsWarnings

Warnings
For external use only.

When using this product
• Avoid contact with eyes • Do not apply to
open wounds or damaged skin
• Avoid using under tight bandages.

Stop use and consult a physician if
symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a
healthcare professional before use.
Keep out of reach of children.
If swallowed, get medical help immediately.

Change to Indications and Usage, Directions sections

RECENT MAJOR CHANGES SECTION

Formatting of the following sections were changed:

  • Indications and Usage
  • Dosage and Administration

Contents remain the same as before.

March 2025

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199189capsaicin 0.025 % / menthol 4 % Topical CreamPSN3
199189capsaicin 0.25 MG/ML / menthol 40 MG/ML Topical CreamSCD3
199189capsaicin 0.025 % / menthol 4 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68981-900-01XENCARE INFLAMAX NATURAL TOPICAL PAIN100 g in 1 BOTTLE, PUMPCREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68981-900XENCARE INFLAMAX NATURAL TOPICAL PAIN (MENTHOL, CAPSAICIN) CREAM [XENEX LABORATORIES INC.]3Current NDC, 1 package rows20250309_25b9621b-3c16-3cb9-e063-6294a90ab598.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68981-90068981-900-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
XENCARE INFLAMAX NATURAL TOPICAL PAINMENTHOL, CAPSAICINXenex Laboratories Inc.25b9621b-3c16-3cb9-e063-6294a90ab5982025-03-06WarningsExact identifier
ndc (package): 68981-900-01
ndc (product): 68981-900
ndc11 (package): 68981090001
spl id: 2fb52ec3-a245-74fa-e063-6394a90a094b
spl set id: 25b9621b-3c16-3cb9-e063-6294a90ab598

Reported adverse events (FAERS/openFDA)#

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