FDA.reportPublic FDA data

Rite Aid Hot and Cold

Manufacturer
Rite Aid Corporation
Effective date
2023-04-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:33:00

Label at a glance#

ProductRite Aid Hot and Cold Extra Strength
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis muscle strains bruises muscle sprains

Dosage and administration

adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • muscle strains
  • bruises
  • muscle sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or irritated or damaged skin
  • do not bandage tightly
  • do not use with a heating pad or apply external heat

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glyceryl stearate, isoceteth-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-795811822-7958-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOCETETH-20O020065R7ZIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TROLAMINE9O3K93S3TKIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
f94d460f-6050-b7a2-e053-6394a90a6c8e9fb3eb7d-9379-4edb-afd6-e5c173b68e822023-04-14WarningsExact identifier
spl id: f94d460f-6050-b7a2-e053-6394a90a6c8e
spl set id: 9fb3eb7d-9379-4edb-afd6-e5c173b68e82

Reported adverse events (FAERS/openFDA)#

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