CBDEZIC- menthol, camphor gel

CBDezic by

Drug Labeling and Warnings

CBDezic by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

Menthol 3.5%

Camphor 0.2%

PURPOSE

Purpose

Menthol ...........Topical Analgesic

Camphor ............Topical Analgesic

INDICATIONS & USAGE

USES: For temporary relief from minor aches

and pains of sore muscles and joints

associated with: arthritis pain backache

strains sprains

WARNINGS

WARNINGS: For external use only.

OTHER SAFETY INFORMATION

Flammable: Keep away from excessive heat or open flame.

ASK DOCTOR

Ask a doctor before use if you have:

Sensitive skin

WHEN USING

When using this product: Avoid contact

with the eyes and/or mucous membranes Do

not use with other sprays, ointments, creams or

liniments Do not apply to irritated skin

Discontinue use if excessive skin irritation

develops Do not bandage Do not use with

heating pads or devices

STOP USE

Stop use and contact your physician if:

conditions worsen, or if symptoms persist for

more than seven (7) days, or clear up and

reoccur.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding: Ask a health 

professional before use

OTHER SAFETY INFORMATION

Children under 2 years of age: Consult physician

KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children: If swallowed,

get medical help or contact a poison control center

immediately.

DOSAGE & ADMINISTRATION

DIRECTIONS: Use only as directed. Rub a

thin film over the affected areas not more than

four (4) times daily. Rinse hands after use with

cool water.

OTHER SAFETY INFORMATION

OTHER INFORMATION: Store in a cool,

dry place with lid closed tightly.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Ethyl Alcohol,

Deionized Water, Glycerin, Propylene Glycol,

Cannabis Sativa Seed Oil (Hemp Seed Oil),

Cannabidiol (CBD), Arnica Montana Flower

Extract (Arnica Oil), Mentha Piperita (Peppermint)

Oil, Mentha Viridis (Spearmint) Leaf Oil, Camellia

Sinensis Leaf Extract, Aloe Barbadensis Leaf

Extract, Hamamelis Virginiana (Witch Hazel)

Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil,

Capsicum Annuum Fruit Extract, Phenoxyethanol,

Caprylyl Alcohol, Ethylhexyl Glycerin, Hexylene

Glycol

Principal Display Package

Dr. Blaine's®

CBDEZIC+®

MEDICAL GRADE PAIN-RELIEVING GEL

MAXIMUM

PAIN

RELIEF

NDC# 63347-225-17

Dr. Blaine's®                                                       50MG

CBDEZIC+®

MEDICAL GRADE PAIN-RELIEVING GEL

1.7 fl oz (50.275mL)

6  16728 00095  8

70001-BX     REV20190315

PHYSICIAN FORMULATED PAIN-RELIEF GEL

MAXIMUM

PAIN

RELIEF

Goes on cool and
   progressively heats

Infused with capsaicin,
   hemp oil, and tea tree oil

Paraben-free formulation

Light formula absorbs into
   the skin rapidly

Longer lasting formula. One
   application offers relief for
   up to 4-6 hours

Provides fast relief from sore
   muscles, aches and pain

           H                        THC√Free
HEMP DERIVED

MADE IN THE USA

MANUFACTURED BY:
BLAINE LABS, INC.
11037 LOCKPORT PLACE,
SANTA FE SPRINGS, CA 90670
www.BLAINELABS.com

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INGREDIENTS AND APPEARANCE

CBDEZIC 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
TEA TREE OIL (UNII: VIF565UC2G)
PAPRIKA (UNII: X72Z47861V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-225-17	1 in 1 BOX	03/01/2019
1		50.275 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/01/2019

Labeler - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-225)