Label: COOL FREEZE- menthol cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 81019-001-01 - Packager: CBDVELVET LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
-
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
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Other Information
-
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
-
INGREDIENTS AND APPEARANCE
COOL FREEZE
menthol creamProduct 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/20/2020 Labeler - CBDVELVET LLC (117698368)
