COOL FREEZE by CBDVELVET LLC 81019-001-01

COOL FREEZE by

Drug Labeling and Warnings

COOL FREEZE by is a Otc medication manufactured, distributed, or labeled by CBDVELVET LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COOL FREEZE- menthol cream 
CBDVELVET LLC

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81019-001-01

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

COOL FREEZE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81019-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CANNABIDIOL (UNII: 19GBJ60SN5)
GLYCERETH-26 (UNII: NNE56F2N14)
AVOCADO OIL (UNII: 6VNO72PFC1)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
TEA TREE OIL (UNII: VIF565UC2G)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81019-001-01	100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/20/2020	11/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/20/2020	11/20/2022

Labeler - CBDVELVET LLC (117698368)

Revised: 1/2025

Document Id: 2b5dd161-87f7-16bf-e063-6394a90ac264

34390-5

Set id: 18c46c90-ffdc-4f13-8139-df0fef1f0975

Version: 2

Effective Time: 20250110