FDA.reportPublic FDA data

Relieve Your Pain

Manufacturer
NATURLAND Magyarorszag Termelo es Kereskedelmi Korlatolt Felelossegu Tarsasag
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:56:45

Label at a glance#

ProductRelieve Your Pain
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Storage and handling

Store in a cool, dry place. Avoid direct sunlight. Tamper-evident for your protection. Use only if safety seal is intact. Keep away from excessive heat or flame.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10%

Purpose

OTC - PURPOSE SECTION

Menthol USP 10%.....................Topical Analgesic

Uses

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

WARNINGS SECTION

Use only as directed. For external use only.

OTC - WHEN USING SECTION

When using this product:

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments.

OTC - STOP USE SECTION

Stop use and ask doctor if:

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and reoccur again within a few days

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

Keep out of reach of children.If accidentally ingested, get medical help or contact Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:

  • Apply to affected area not more than 3 to 4 times daily.

Other Information

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Magnesium Chloride, Dimethyl Sulfone (Methylsulfonylmethane), Glyceryl Stearate SE, Cetearyl Alcohol, Sweet Almond Oil (Prunus Amygdalus Dulcis), Shea Butter (Butyrospermum Parkii), Ceteareth-20, Glycerin, Pentylene Glycol, Undecane, Tocopheryl Acetate, Cetyl Palmitate, Arnica Montana Flower Extract, Tocopherol, Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone

Questions or Comments?

OTC - QUESTIONS SECTION

888-819-6472; Monday-Friday, 9am-5pm CT

Report any serious side effects to number above.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72683-005-01

Non-toxic

Paraben Free

Asutra*

Relieve

your

pain

10% Menthol

Pain Relief Cream

With Moisturizing

Magnesium and

Arnica Montana

Net Wt. 3.4 oz. | 96 g.

11

22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84618-005RELIEVE YOUR PAIN (MENTHOL) CREAM [NATURLAND MAGYARORSZAG TERMELO ES KERESKEDELMI KORLATOLT FELELOSSEGU TARSASAG]1Unmatched20240815_1f9172c7-5cc2-8e8c-e063-6394a90a10e9.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84618-00584618-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIDECANEA3LZF0L939IACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETYL PALMITATE5ZA2S6B08XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM CHLORIDE660YQ98I10IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
SODIUM CHLORIDE451W47IQ8XIACT
SHEA BUTTERK49155WL9YIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
UNDECANEJV0QT00NUEIACT
ASCORBYL PALMITATEQN83US2B0NIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
WATER059QF0KO0RIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALMOND OIL66YXD4DKO9IACT
MENTHOLL7T10EIP3AACTIB

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
37da3de2-528e-191b-e063-6394a90a3c7a1f9172c7-5cc2-8e8c-e063-6394a90a10e92025-06-18WarningsExact identifier
spl set id: 1f9172c7-5cc2-8e8c-e063-6394a90a10e9

Reported adverse events (FAERS/openFDA)#

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