CBD UNLIMITED MISTX TOPICAL ANALGESIC- menthol and camphor spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727)
Available from:
ENDEXX CORPORATION
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple backache, strains, sprains
Authorization status:
OTC monograph not final
Authorization number:
73045-002-30

CBD UNLIMITED MISTX TOPICAL ANALGESIC- menthol and camphor spray

ENDEXX CORPORATION

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.

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CBD UNLIMITED MISTX TOPICAL ANALGESIC

Active ingredient

Menthol USP 5%

Camphor 3.25%

Purpose

Topical Analgesic

Inactive ingredients

Arnica Oil, Clove Bud Oil, Eucalyptus Globus Oil, Hemp, Isopropyl Alcohol, MSM

(Methylsulfonylmethane), Peppermint Oil, Sweet Birch Oil.

Uses

Temporary relief from minor aches and pains of muscles & joints associated with: arthritis, simple

backache, strains, sprains

Warnings:

For external use only.

Flammable: Keep away from excessive heat or open flame.

Do not use on wounds or damaged skin.

When using this product: Avoid contact with the eyes. Do not bandage tightly.

Stop use and ask a doctor ifcondition worsens, or if symptoms persist for more than 7 days or clear

up and occur again within a few days.

If pregnant or breast-feeding ask a health professional before use.

Keep Out of Reach of Children

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

Keep Out of Reach of Children

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

Directions:

Adults and children 12 years of age & older. Spray a thin flim over affected area not more than 3 to 4

times daily: massage not necessary, for children 12 years or younger, consult a doctor.

Distributed By:

CBD UNLIMITED INC

Principal Display Panel

CBD UNLIMITED MISTX

TOPICAL ANALGESIC

1 fl. oz. (30mL) Spray

CBD UNLIMITED MISTX TOPICAL ANALGESIC

menthol and camphor spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 45-0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

5 g in 10 0 mL

CAMPHO R O IL (UNII: 75IZZ8 Y727) (CAMPHOR OIL - UNII:75IZZ8 Y727)

CAMPHOR OIL

3.25 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

HEMP (UNII: TD1MUT0 1Q7)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

CLO VE O IL (UNII: 578 38 9 D6 D0 )

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

Packag ing

#

Item Code

Package Description

Marketing Start

Marketing End

ENDEXX CORPORATION

#

Item Code

Package Description

Date

Date

1

NDC:730 45-0 0 2-

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/12/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 4/12/20 19

Labeler -

ENDEXX CORPORAT ION (002119594)

Registrant -

ENDEXX CORPORAT ION (002119594)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Signature Fo rmulatio ns LLC

0 79 126 258

MANUFACTURE(730 45-0 0 2)

Revised: 4/2019

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