Label: CBD (camphor- synthetic cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64479-400-01 - Packager: SmartScience Laboratories, Inc.
- 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 February 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Directions
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Warnings
For external use only: Flammable: Keep away from excessive heat or open flame.
When using this product
Do not use on wounds or irritated skin
- Do not bandage tightly or use with a heating pad
- Wash hands after use with cool water
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Inactive Ingredients
Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aescin (Horse Chestnut Extract), Aloe Vera, Arnica Montana Extract, C12-15 Alkyl Benzoate, Chondroitin Sulfate, Diazodinyl Urea, Dimethicone, Disodium EDTA, dl Panthenol, Fructoborate, Cannabis Sativa Oil (Hemp Derived), Glucosamine Sulfate, Glycerin, Glycerol Stearate, Hydroxypropyl methylcellulose, Iodopropynyl Butylcarbamate, Methyl Gluceth-20, Methyl Glucose Sesquistearate, Peppermint Oil, Polysorbate 20, Potassium Carbomer, Purified Water, Shea Butter, Tocopheryl Acetate, Trolamine Salicylate
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 114 g Jar Label
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INGREDIENTS AND APPEARANCE
CBD
camphor (synthetic) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64479-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 5 mg in 100 g Inactive Ingredients Ingredient Name Strength Methyl Glucose Sesquistearate (UNII: V1YW10H14D) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA (UNII: O80TY208ZW) CALCITRIOL (UNII: FXC9231JVH) CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH) Diazolidinyl Urea (UNII: H5RIZ3MPW4) Iodopropynyl Butylcarbamate (UNII: 603P14DHEB) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Escin (UNII: RUU8G67GQM) GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N) Glycerin (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Methyl Gluceth-20 (UNII: J3QD0LD11P) Peppermint Oil (UNII: AV092KU4JH) Potassium Hydroxide (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) Shea Butter (UNII: K49155WL9Y) Sorbitan Monolaurate (UNII: 6W9PS8B71J) Trolamine Salicylate (UNII: H8O4040BHD) Cannabidiol (UNII: 19GBJ60SN5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64479-400-01 114 g in 1 JAR; Type 0: Not a Combination Product 02/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 02/12/2020 Labeler - SmartScience Laboratories, Inc. (035907919)