FDA.reportPublic FDA data

Relieve Your Pain

Manufacturer
Proximity Capital Partners LLC dba Asutra | BioLyte Laboratories, LLC
Effective date
2025-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:26

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253020menthol 10 % Topical CreamPSN3
253020menthol 100 MG/ML Topical CreamSCD3
253020menthol 10 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72683-005-012024-08-13C16284748780-11e7a6dab-1aab-a2ce-e063-dadaa90aadf7Relieve Your Pain (Asutra)
72683-005-012024-07-30C16284748780-11e7a6dab-1aab-a2ce-e063-dadaa90aadf7Relieve Your Pain (Asutra)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72683-005-01Relieve Your Pain96 g in 1 TUBECREAM963

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
72683-00572683-005-01

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
GLYCERYL STEARATE SEFCZ5MH785IIACT
ALMOND OIL66YXD4DKO9IACT
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
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
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
ndc (package): 72683-005-01
ndc (product): 72683-005
ndc11 (package): 72683000501
spl id: 37da2fc9-ec10-f56d-e063-6294a90a64ae
spl set id: c12369dd-8305-edaf-e053-2995a90a0d3d

Reported adverse events (FAERS/openFDA)#

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