FDA.reportPublic FDA data

NOT POT CBD ICY Cooling Pain Relief

Manufacturer
Blemish, Inc
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:16:53

Label at a glance#

ProductNOT POT CBD ICY Cooling Pain Relief
Active ingredientMETHYL SALICYLATE, MENTHOL
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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 12.0%
Menthol 5.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with:

  • arthritis
  • backache
  • sprains
  • bruises
  • strains.

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 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/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel)Juice, Aqua (Deionize Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Etract, Copper Sulfate, Ilex Paraguariensis (Yerba Mate Extract), Isopropyl Alcohol, Isopropyl Myristate, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
80331-07780331-077-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
HEMPTD1MUT01Q7IACT
CUPRIC SULFATELRX7AJ16DTIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB

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
0749468a-c47f-21be-e063-6294a90a35e5dfc594b2-3fd8-4ec6-a826-850528850dca2023-10-09WarningsExact identifier
spl set id: dfc594b2-3fd8-4ec6-a826-850528850dca

Reported adverse events (FAERS/openFDA)#

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