CBDMEDIC MASSAGE THERAPY PAIN RELIEF- camphor and menthol. oil

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

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Active ingredient:
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Camphor 3%, Menthol 4% (External Analgesics) Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
Authorization status:
OTC monograph not final
Authorization number:
24909-736-04

CBDMEDIC MASSAGE THERAPY PAIN RELIEF- camphor and menthol. oil

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 Massage Therapy Pain Relief

Active Ingredients and Purpose

Camphor 3%, Menthol 4% (External Analgesics)

Us es

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache,

arthritis, strains, bruises and sprains.

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 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

Argan oil, coconut oil (MCT oil), cotton seed oil, frankincense oil, hemp extract (THC-

free), honeysuckle oil, jojoba seed oil, myrrh oil

PRINCIPAL DISPLAY PANEL

CBDMEDIC MASSAGE THERAPY PAIN RELIEF

camphor and menthol. oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:249 0 9 -736

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

30 mg

in 1 mL

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

MENTHOL

40 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ARGAN O IL (UNII: 4V59 G5UW9 X)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

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

FRANKINCENSE O IL (UNII: 6 7ZYA5T0 2K)

HEMP (UNII: TD1MUT0 1Q7)

LO NICERA CO NFUSA WHO LE (UNII: 22L2C7GWOA)

JO JO BA O IL (UNII: 724GKU717M)

AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

MYRRH O IL (UNII: H74221J5J4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:249 0 9 -736 -0 4

1 in 1 CARTON

0 3/0 6 /20 19

1

10 4 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

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 6 /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 -736 ) , label(249 0 9 -736 )

Revised: 3/2019

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