FDA.reportPublic FDA data

Cold and Hot

Manufacturer
Product Quest Mfg, LLC
Effective date
2018-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:29

Label at a glance#

ProductCold and Hot Scherer Labs
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

• shake well • adults and children 2 years of age and older: spray product on affected area, not more than 3 to 4 times daily. • children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.60%
Methyl Salicylate 29.00%


Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable • keep away from fire or flame • do not use while smoking or
near heat or flame • avoid long term storage above 104˚F. • do not puncture
or incinerate. Contents under pressure. • do not store at temperatures
above 120˚F.
When using this product • avoid contact with eyes and mucous
membranes • do not apply to wounds or damaged skin • do not bandage
tightly • use only as directed
Stop use and ask doctor if • condition worsens • symptoms persist for
more than 7 days or clear up and occur again within a few days • needed for
longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well • adults and children 2 years of age and older:
spray product on affected area, not more than 3 to 4 times
daily. • children under 2 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Arnica Montana Flower Extract
Boswellia Serrata Gum Extract
Dimethyl Sulfone
Eucalyptus Globulus Leaf Oil
Ilex Paraguariensis Leaf Extract
Mentha Piperita (Peppermint) Oil
Olea Europaea (Olive) Fruit Oil
Propylene Glycol
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1596759menthol 7.6 % / methyl salicylate 29 % Topical SprayPSN1
1596759menthol 76 MG/ML / methyl salicylate 290 MG/ML Topical SpraySCD1
1596759menthol 7.6 % / methyl salicylate 29 % Topical SpraySY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64048-3334-42020-01-31C16284748780-19d75b9cf-ce84-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64048-3334-4Cold and HotScherer Labs113 g in 1 CANSPRAY1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64048-3334COLD AND HOT SCHERER LABS (MENTHOL 7.6% MEHYL SALICYLATE 29.0%) SPRAY [PRODUCT QUEST MFG, LLC]1Legacy NDC, 1 package rows20180510_124ab53a-ab46-4fe6-b5c4-8ddf8b46062e.zip

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
64048-333464048-3334-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
EUCALYPTUS OIL2R04ONI662IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
OLIVE OIL6UYK2W1W1EIACT
Propylene Glycol6DC9Q167V3IACT

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
57543e42-fb49-4c61-87a7-ebf93203c30f124ab53a-ab46-4fe6-b5c4-8ddf8b46062e2018-05-10WarningsExact identifier
spl id: 57543e42-fb49-4c61-87a7-ebf93203c30f
spl set id: 124ab53a-ab46-4fe6-b5c4-8ddf8b46062e

Reported adverse events (FAERS/openFDA)#

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