CBDMEDIC ARTHRITIS PAIN RELIEF- menthol. cream

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Menthol 4% (External Analgesic) Temporarily relieves minor aches and pains of muscles and joints associated with arthritis.
Authorization status:
OTC monograph not final
Authorization number:
24909-740-48

CBDMEDIC ARTHRITIS PAIN RELIEF- menthol. cream

AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

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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CBDMEDIC Arthritis Pain Relief

Active Ingredient and Purpose

Menthol 4% (External Analgesic)

Us es

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis.

Warnings

For external use only. Do not use on wounds or damaged skin. When using this product: avoid

contact with eyes or mucous membranes do not bandage tightly or use with a heating pad. Stop use

and ask a doctor if: condition worsens, or symptoms persist for more than 7 days symptoms clear up

and occur again within a few days excessive skin irritation develops.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center immediately.

Directions

Adults and children 12 years of age and older: massage cream into affected area not more than 3 to 4

times daily. Wash hands with soap and water after use. Children under 12 years of age: ask a doctor.

Inactive ingredients

Beeswax (organic), clove oil, cotton seed oil, emulsifying wax, eucalyptus oil, hemp extract (THC-

free), jojoba seed oil, peppermint oil, purified water, shea butter, sorbic acid, tea tree oil

PRINCIPAL DISPLAY PANEL

CBDMEDIC ARTHRITIS PAIN RELIEF

menthol. cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:249 0 9 -740

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

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WHITE WAX (UNII: 7G1J5DA9 7F)

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

CO TTO NSEED O IL (UNII: H3E8 78 0 20 N)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

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

HEMP (UNII: TD1MUT0 1Q7)

JO JO BA O IL (UNII: 724GKU717M)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

WATER (UNII: 0 59 QF0 KO0 R)

SHEA BUTTER (UNII: K49 155WL9 Y)

AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

TEA TREE O IL (UNII: VIF56 5UC2G)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:249 0 9 -740 -

1 in 1 CARTON

0 3/0 4/20 19

1

48 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

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 3/0 4/20 19

Labeler -

AIDANCE SKINCARE & T OPICAL SOLUT IONS, LLC (018950611)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Aidance Skincare & To pical So lutio ns, LLC

0 18 9 50 6 11

manufacture(249 0 9 -740 ) , label(249 0 9 -740 )

Revised: 3/2019

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