FDA.reportPublic FDA data

CVS Extra Strength Cold and Hot Medicated Patch

Manufacturer
CVS Pharmacy, Inc.
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:55:19

Label at a glance#

ProductCVS Extra Strength Cold and Hot Medicated Patch
Active ingredientMENTHOL
Label structure11 sections

Storage and handling

Other information store at room temperature, not to exceed 86°F(30°)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                           Purpose

Menthol 5%....................................Topical analgesic

OTC - PURPOSE SECTION

Uses Temporarily relieves minor pain associated with

  • arthritis 
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

WARNINGS SECTION

Warnings

For external use only

  • If pregnant or breast feeding, ask a health professional before use.

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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.

INDICATIONS & USAGE SECTION

Directions adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • should be used up to 8 hours
  • should be used no more than 3 times a day
  • children under 12 years of age consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature, not to exceed 86°F(30°)

INACTIVE INGREDIENT SECTION

Inactive ingredients

1,3-butylene glycol, aloe vera, butylated hydroxytoluene, edetate disodium, gelatin, glycerin, kaolin, magnesium aluminum hydroxide, metacrylic acid butylacrylate copolymer, methylparaben, mineral oil, poysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, sorbitol, tartaric acid, titanium dioxide, tocopherol acetate

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-426-05EA - Each59779-426f7c4421b-208b-4b2e-a6f9-5e93c17b6cf912020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
KAOLININACTIVE INGREDIENT24H4NWX5CO1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD561
SORBITOLINACTIVE INGREDIENT506T60A25R1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59779-42659779-426-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
SODIUM METAPHOSPHATE532IUT7IRVIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
PARAFFINI9O0E3H2ZEIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITOL506T60A25RIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 384 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR11 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCREAM / VAGINAL0.4 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
KAOLINKAOLIN24H4NWX5COCAPSULE, EXTENDED RELEASE / ORAL21 mgExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HTABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET / SUBLINGUAL0.08 mgExact identifier — unii candidate
78 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HSUSPENSION / ORAL40 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HCAPSULE / ORAL400 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, SOLUTION / INTRAMUSCULAR18 mgExact identifier — unii candidate
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HDROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HTABLET, FILM COATED / ORAL30 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS20 mgExact identifier — unii candidate
24 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HLIQUID / INTRAVENOUS720 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

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
d2431a76-82aa-1dff-e053-2995a90a89f72469d1f3-394d-4bd1-b8df-fab83bbfe2542021-12-03WarningsExact identifier
spl set id: 2469d1f3-394d-4bd1-b8df-fab83bbfe254

Reported adverse events (FAERS/openFDA)#

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