COOL CURE Pain Relief Cream

Manufacturer
SDRH Inc
Effective date
2019-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:31:34

Label at a glance#

ProductCOOL CURE Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: apply to affected area not more than three to four times daily.  Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporary relief of minor pain.

WARNINGS

WARNINGS SECTION

  • For external use only. Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age or older: apply to affected area not more than three to four times daily. 
  • Children under two-years of age: consult a physician.

ADDITIONAL INFORMATION:

SPL UNCLASSIFIED SECTION

Store at room temperature.

OTHER INGREDIENTS:

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Camphor, Cetyl Esters, Cetyl Myristoleate, Dimethicone, DMDM Hydantoin, Emu Oil, Ethylhexylglycerin, Ethoxydiglycol, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Gluceth 20, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Salix Alba (Willow) Bark Extract, Steareth-20, Tocopheryl Acetate (Vitamin E) Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72859-89072859-890-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
0721253e-b504-5b59-e063-6294a90ae1a2d8f6af02-845c-4825-86c0-0a6fa44dbde12023-10-07WarningsExact identifier
spl set id: d8f6af02-845c-4825-86c0-0a6fa44dbde1

Reported adverse events (FAERS/openFDA)#

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