FDA.reportPublic FDA data

MERCY PAIN RELIEVING LOTION

Manufacturer
Cloud 9 Naturally
Effective date
2018-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:35

Label at a glance#

ProductMERCY PAIN RELIEVING
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

temporarily relieves 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. • children under 2 years of age: consult a doctor.

Storage and handling

do not use if seal or cap is broken.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints associated with

• simple backache • arthritis  • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

• avoid contact with the eyes and mucous membranes

• do not apply to wounds or damaged skin

• do not bandage tightly

Stop use and ask a doctor if

• condition worsens

• symptoms persist for more than 7 days

• clear up and occur again within a few days

If pregnant or breast-feeding, consult 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.

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.

• children under 2 years of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetyl Alcohol, Fragrance, Glycerin, Methylsulfonylmethane (MSM), Olive (Oleo Europaea) Oil, Stearic Acid, Water

Other information

STORAGE AND HANDLING SECTION

do not use if seal or cap is broken.

Questions?

OTC - QUESTIONS SECTION

1-403-348-9704, Mon-Fri, 9AM to 5 PM.

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Soothes minor pain of

• muscles • joints • backache • arthritis 

Manufactured by:

Cloud 9 Naturally Inc,

53840 National Rd, Lower unit,

Bridgeport, Ohio, 43912 USA

www.cloud9naturally.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mercy Pain Relieving LotionMercy Pain Relieving Lotion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2045268menthol 1.3 % Topical LotionPSN2
2045268menthol 13 MG/ML Topical LotionSCD2
2045268menthol 1.3 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72070-100-012020-01-31C16284748780-19d75b9cf-fa6d-f424-e053-dadaa90a57ceMERCY PAIN RELIEVING LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72070-100-01MERCY PAIN RELIEVING113.4 g in 1 BOTTLELOTION113.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72070-100MERCY PAIN RELIEVING (MENTHOL) LOTION [CLOUD 9 NATURALLY]2Legacy NDC, 1 package rows20180518_aa584c8f-ab36-474d-af63-49471b900a21.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72070-10072070-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
OLIVE OIL6UYK2W1W1EIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT

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
8c6e9a62-838e-4231-8ead-3ea8b76febd5aa584c8f-ab36-474d-af63-49471b900a212018-05-18WarningsExact identifier
spl id: 8c6e9a62-838e-4231-8ead-3ea8b76febd5
spl set id: aa584c8f-ab36-474d-af63-49471b900a21

Reported adverse events (FAERS/openFDA)#

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