CBDAF TOPICAL GEL- lidocaine hydrochloride, menthol gel

CBDaF by

Drug Labeling and Warnings

CBDaF by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hydrochloride 4%, Menthol 1%

Purpose

Topical Analgesic

Uses

Use for temporary relief of minor pain

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

Kepp out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding

ask a health professional before use.

Directions

Adults and children over 12 years:

apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily

if product comes in contact hands, wash hands with soap and water

children 12 years or younger: ask a doctor

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

480.562.6282

CBDaF CBD & lidocaine Topical Gel

INGREDIENTS AND APPEARANCE

CBDAF  TOPICAL GEL
lidocaine hydrochloride, menthol gel

Product 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)