Label: CBDAF TOPICAL GEL- lidocaine hydrochloride, menthol gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 58443-0366-3 - Packager: Prime Enterprises
- 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 October 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only.
Do not use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
When using this product
Use only as directed
Avoid contact with eyes and mucous membranes
Do not apply to skin folds
Do not apply to wounds or damaged, broken or irritated skin
Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
Stop use and ask doctor if
condition worses
irriation develops
redness appears
symptoms persist for more than 7 days or clear up and occurs again within a few days
- Directions
-
Inactive ingredients
Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Cannabidiol, Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water
- Questions and comments
- CBDaF CBD & lidocaine Topical Gel
-
INGREDIENTS AND APPEARANCE
CBDAF TOPICAL GEL
lidocaine hydrochloride, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0366 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9.62 mg in 1 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 38.48 mg in 1 mL Inactive Ingredients Ingredient Name Strength ACRYLAMIDE (UNII: 20R035KLCI) SODIUM ACRYLATE (UNII: 7C98FKB43H) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) WATER (UNII: 059QF0KO0R) TRIDECETH-6 (UNII: 3T5PCR2H0C) CHAMOMILE (UNII: FGL3685T2X) MINERAL OIL (UNII: T5L8T28FGP) SODIUM HYDROXIDE (UNII: 55X04QC32I) HORSE CHESTNUT (UNII: 3C18L6RJAZ) PEPPERMINT OIL (UNII: AV092KU4JH) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) SALIX ALBA BARK (UNII: 205MXS71H7) BORAGE SEED OIL (UNII: F8XAG1755S) TURMERIC (UNII: 856YO1Z64F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) BLACK CURRANT (UNII: 9755T40D11) ALCOHOL (UNII: 3K9958V90M) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) POLYSORBATE 20 (UNII: 7T1F30V5YH) CANNABIDIOL (UNII: 19GBJ60SN5) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white (White to Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0366-3 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/01/2019 Labeler - Prime Enterprises (101946028) Registrant - Prime Enterprises (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises 101946028 manufacture(58443-0366) , label(58443-0366) , analysis(58443-0366) , pack(58443-0366)
