Cvs Extra Strength Cold And Hot Medicated

Manufacturer
Bershtel Enterprises
Effective date
2018-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:02:42

Label at a glance#

ProductCvs Extra Strength Cold And Hot Medicated
Active ingredientMENTHOL
Label structure11 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

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

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

OTC - PURPOSE SECTION

Temporarily relieves minor pain associated with:

arthritis
simple backache
bursitis
tendonitis
muscle strains
muscle sprains
bruises
cramps

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

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

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

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°C)

WARNINGS SECTION

Warnings

For external use only

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

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, polysorbate 80, purified water, sodium methaphosphate, sodium polyacrylate, sorbitan monooleate, sorbitol, tartaric acid, titanium dioxide, tocopherol acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product cartonproduct carton

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10564-426010564-4260-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
b8304f03-9522-6d8c-e053-2a95a90a3a2963751e77-51cb-37f0-e053-2991aa0a30e32021-01-05WarningsExact identifier
spl set id: 63751e77-51cb-37f0-e053-2991aa0a30e3

Reported adverse events (FAERS/openFDA)#

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