Indications and uses
Aid for temporary local relief of minor pain in muscles or joints associated with general backpain, strains, sprains and bruises.
COOL FREEZE
- Manufacturer
- CBDVELVET LLC
- Effective date
- 2021-01-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:57:02
Label at a glance#
ProductCOOL FREEZE
Active ingredientMENTHOL
Label structure8 sections
Dosage and administration
Adults and children over 16 years of age. Apply to affected area not more than three to four times daily. Children 16 years of age or younger, consult a physician.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredients
Menthol 10%
Purpose
Topical analgesic.
Warnings
For external use only,
- Avoid Contact with eyes.
- Do not apply to wounds or damaged skin.
- If symptoms persist for more than seven days discontinue use and consult a physician.
- If pregnant or breastfeeding contact a health professional before use.
- keep out of reach of children.If swallowed get medical help or contact a poison control right away.
Emergency Number: 1-800-222-1222
Uses
Aid for temporary local relief of minor pain in muscles or joints associated with general backpain, strains, sprains and bruises.
Directions
- Adults and children over 16 years of age.
- Apply to affected area not more than three to four times daily.
- Children 16 years of age or younger, consult a physician.
Other Information
Store in a cool, dry place with lid closed tightly.
Inactive Ingredients
Aqua,Caprylic/Capric Triglycereide, Alcohol Denat., Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Caprylyl Glycol, Phenoxyethanol,
Hexylene Glycol, Helianthus Annuus Seed Oil (Sunflower Oil), Butyrospermum Parkii Butter, Hemp-Derived Cannabidiol (CBD), Glycereth-26, Persea Gratissima Oil (Avocado Oil), Stearyl Alcohol, Sodium Polyacrylate, Aloe Barbadensis Leaf Extract (Aloe Vera), Glycerin,Boswellia Serrata Extract Melaleuca Alternifolia Leaf Oil (Tea Tree Oil), Mentha Arvensis Herb Oil, Arnica Montana Flower Extract.
Product label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81019-001-01 | 2025-01-14 | C162847 | 48780-1 | f386c64a-24e8-0266-e053-dadaa90a7c1a | 18c46c90-ffdc-4f13-8139-df0fef1f0975 |
| 81019-001-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-24e8-0266-e053-dadaa90a7c1a | 18c46c90-ffdc-4f13-8139-df0fef1f0975 |
Products#
Every source-derived product name is available through these pages.
- COOL FREEZE
- Menthol
- WATER
- MEDIUM-CHAIN TRIGLYCERIDES
- ALCOHOL
- STEARIC ACID
- CETYL ALCOHOL
- DIMETHICONE
- GLYCERYL MONOSTEARATE
- CAPRYLYL GLYCOL
- PHENOXYETHANOL
- HEXYLENE GLYCOL
- SUNFLOWER OIL
- BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES
- CANNABIDIOL
- GLYCERETH-26
- AVOCADO OIL
- STEARYL ALCOHOL
- SODIUM POLYACRYLATE (2500000 MW)
- ALOE VERA LEAF
- GLYCERIN
- INDIAN FRANKINCENSE
- TEA TREE OIL
- MENTHA ARVENSIS FLOWER OIL
- ARNICA MONTANA FLOWER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81019-001 | 81019-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b5dd161-87f7-16bf-e063-6394a90ac264 | 18c46c90-ffdc-4f13-8139-df0fef1f0975 | 2025-01-10 | Warnings | 18c46c90-ffdc-4f13-8139-df0fef1f0975 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.