Label: CBD UNLIMITED TOPICAL ANALGESIC- menthol and camphor spray
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Contains inactivated NDC Code(s)
NDC Code(s): 73045-004-01, 73045-004-02, 73045-004-03 - Packager: ENDEXX CORPORATION
- 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 May 5, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings:
For external use only.
When using this product:
• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• do not spray onto face
• avoid inhaling spray mist and fumesStop use and ask doctor if:
• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clears up and occurs again within a few days
Flammable
do not use near heat or open flame or while smoking
If pregnant or breast-feeding, ask a healthcare professional before use
- Keep Out of Reach of Children
- Directions:
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CBD UNLIMITED TOPICAL ANALGESIC
menthol and camphor sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73045-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 50 mg in 1 mL CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL 325 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) EUCALYPTUS OIL (UNII: 2R04ONI662) CLOVE OIL (UNII: 578389D6D0) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) Dimethyl Sulfone (UNII: 9H4PO4Z4FT) GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN) Cannabidiol (UNII: 19GBJ60SN5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73045-004-01 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/05/2020 2 NDC:73045-004-02 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/05/2020 3 NDC:73045-004-03 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/05/2020 Labeler - ENDEXX CORPORATION (002119594) Registrant - ENDEXX CORPORATION (002119594) Establishment Name Address ID/FEI Business Operations Velocity Production and Packaging 081076893 manufacture(73045-004)
