FDA.reportPublic FDA data

ExaltHemp Hot and Cold Pain Cream

Manufacturer
BioSerene Inc.
Effective date
2023-05-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:31:28

Label at a glance#

ProductExaltHemp Hot and Cold Pain Cream
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles.

Dosage and administration

Adults and children 12 years of age and older: Massage over affected areas no more than 3 to 4 times daily. Wash hands after use. Children under 12 years of age: consult a doctor.

Storage and handling

Store at controlled room temperature 20°-25°C (68°-77°F). Keep away from direct sunlight.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%, Methyl Salicylate 4%

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backaches, strains, bruises, sprains, and pulled muscles.

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Massage over affected areas no more than 3 to 4 times daily. Wash hands after use.
Children under 12 years of age: consult a doctor.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

Flammable. Keep away from fire or flame.

Allergy Alert. If prone to allergic reaction from aspirin or salicylates, consult doctor before use.

Do Not Use

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin or with a heating pad.

When Using This Product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop Use and Ask a Doctor

OTC - STOP USE SECTION

  • If condition worsens
  • Symptoms persist more than 7 days or clear up and occur again within a few days
  • Excessive skin irritation develops

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 immediately.

Storage and Handling

STORAGE AND HANDLING SECTION

Store at controlled room temperature 20°-25°C (68°-77°F). Keep away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Menthol, Gaultheria Procumbens (Wintergreen) Leaf Oil, Fractionated Coconut Oil, Polysorbate 80, Sorbitan Stearate, Cetearyl Alcohol, Isopropyl Myristate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cannabidiol, Dimethyl Isosorbide, Oenothera Biennis (EveningPrimrose) Oil, Tocopherol Acetate (VitaminE), Propylene Glycol, Diazolidinyl Urea, Iodopropynyl Butylcarbamate

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ExaltHemp Hot & Cold Pain Cream - For Tired Joints & Muscles

Hemp Extract CBD 1200MG (for 100mL)

CBD Isolate 12mg/ml

  • Made in USA
  • Formulated By a Pharmacist
  • cGMP Certified

Manufactured By: BioSerene, Inc.

4398 SW Port Way, Palm City, FL 34990 USA

ExaltHemp Hot and Cold Cream LabelExaltHemp Hot and Cold Cream Label

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74787-190174787-1901-3, 74787-1901-2, 74787-1901-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
METHYL SALICYLATELAV5U5022YACTIB
CANNABIDIOL19GBJ60SN5IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
MENTHOLL7T10EIP3AACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYSORBATE 806OZP39ZG8HIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT

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
fb71db58-d321-9dbe-e053-6294a90aeb6ae1f9f691-e0d1-a098-e053-2a95a90a91842023-05-11WarningsExact identifier
spl id: fb71db58-d321-9dbe-e053-6294a90aeb6a
spl set id: e1f9f691-e0d1-a098-e053-2a95a90a9184

Reported adverse events (FAERS/openFDA)#

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