PR

Manufacturer
Amphp, Inc
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:40:59

Label at a glance#

ProductPR
Active ingredientMENTHOL
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

OTC - PURPOSE SECTION

Pain relieving sports lotion

INDICATIONS & USAGE SECTION

For the temporary relief of pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if allergic to any ingredient in this product or sensitive to sodium

OTC - WHEN USING SECTION

Use only as directed. Avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask doctor if:

Symptoms persist for more than 7 days

Symptoms clear up and occur 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 swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.

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

Children under 2 years of age: consult a doctor

OTHER SAFETY INFORMATION

Store at 20-25C (68-77F)

INACTIVE INGREDIENT SECTION

sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance

PR Lotion 300 gram tube principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Standard TubeStandard Tube

PR Lotion 20 gram packet principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

On-The-Go PacketOn-The-Go Packet

PR Lotion 100 gram tube principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Travel TubeTravel Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293193menthol 0.5 % Topical LotionPSN9
1293193menthol 5 MG/ML Topical LotionSCD9
1293193menthol 0.5 % Topical LotionSY9

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860000289214GTIN-13: 0860000289214
EAN-13: 0860000289214
GTIN-12: 860000289214
UPC-A: 860000289214
GTIN storage (14 digits): 00860000289214
Amp-Standard-Tube_Front-Back (1).jpg
BarcodeEAN-130860000289221GTIN-13: 0860000289221
EAN-13: 0860000289221
GTIN-12: 860000289221
UPC-A: 860000289221
GTIN storage (14 digits): 00860000289221
Amp_Travel-Tube_Front-Back (1).jpg
BarcodeEAN-130860000289238GTIN-13: 0860000289238
EAN-13: 0860000289238
GTIN-12: 860000289238
UPC-A: 860000289238
GTIN storage (14 digits): 00860000289238
Amp_On-The-Go-Front.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72358-101-032025-03-03C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-03-03C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-03-03C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-03-03C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-01-30C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032025-01-30C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-01-30C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-042025-01-30C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-02-14C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-012022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-022022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737
72358-101-032022-01-28C16284748780-1d6a99b39-980e-a426-e053-dadaa90af4c26f5b9e08-c445-4fac-e053-2a91aa0aa737

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72358-101-03PR20 g in 1 PACKETLOTION209
72358-101-04PR300 g in 1 BOTTLE, PLASTICLOTION3009

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72358-10172358-101-04, 72358-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-03-03full-release2026-06-01 00:56:34

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
PRMENTHOLAmphp, Inc6f5b9e08-c445-4fac-e053-2a91aa0aa7372025-10-27WarningsExact identifier
ndc (package): 72358-101-04
ndc (package): 72358-101-03
ndc (product): 72358-101
ndc11 (package): 72358010103
ndc11 (package): 72358010104
spl id: 4229f4ae-8934-0e10-e063-6394a90a4185
spl set id: 6f5b9e08-c445-4fac-e053-2a91aa0aa737

Reported adverse events (FAERS/openFDA)#

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