External Analgesic Cream with Menthol 5%

Manufacturer
BLOOMWELL GARDENS LLC | Jiangxi Zhongletang Pharmaceuticals Co., Ltd.
Effective date
2026-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:46:27

Label at a glance#

ProductExternal Analgesic Cream with Menthol 5%
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol 5%

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin,

Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol,

Mentha Arvensis Leaf, Chrysanthemum Indicum Top,

Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

avoid contact with eyes,

mucous membranes do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if: condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

DOSAGE & ADMINISTRATION SECTION

- Adults and children 12 years and older:

Clean the affected area with mild soap and warm water, then pat dry.

Apply a thin, even layer to the affected area not more than 3 to 4 times

daily.

- Children under 12 years: consult a doctor

OTC - PURPOSE SECTION

Temporary relief of minor aches and pains

OTC - DO NOT USE SECTION

on wounds or damaged skin with a heating pad

if allergic to menthol or any ingredient in this product

OTHER SAFETY INFORMATION

Store at 15–30°C (59–86°F)

Protect from excessive moisture and direct sunlight

Keep the carton for full labeling

Flammable: keep away from fire or flame

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Principal Display PanelPackage Label Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN2
1039690menthol 50 MG/ML Topical CreamSCD2
1039690menthol 5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85284-010-01External Analgesic Cream with Menthol 5%50 g in 1 BOTTLECREAM502

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85284-01085284-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
ndc (package): 85284-010-01
ndc (product): 85284-010
ndc11 (package): 85284001001
spl id: 4b1bbf88-7c2d-e616-e063-6394a90a0864
spl set id: 402faa27-5305-c73d-e063-6394a90a36f2

Reported adverse events (FAERS/openFDA)#

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