CBDMEDIC BACK AND NECK RELIEF- camphor and menthol. ointment

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 10%, Menthol 15% (External Analgesics) Temporarily relieves minor aches and pains of muscles and joints associated with simple backache and neck strains.
Authorization status:
OTC monograph not final
Authorization number:
24909-726-25, 24909-726-40

CBDMEDIC BACK AND NECK RELIEF- camphor and menthol. ointment

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 BACK AND NECK RELIEF

Active Ingredients and Purpose

Camphor 10%, Menthol 15% (External Analgesics)

Us es

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

neck strains.

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 ointment 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, eucalyptus oil, hemp extract (THC-free), jojoba seed oil,

peppermint oil, sorbic acid, tea tree oil

PRINCIPAL DISPLAY PANEL

CBDMEDIC BACK AND NECK RELIEF

camphor and menthol. ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:249 0 9 -726

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)

10 0 mg

in 1 g

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

MENTHOL

150 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)

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)

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

AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC

TEA TREE O IL (UNII: VIF56 5UC2G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:249 0 9 -726 -40

1 in 1 CARTON

0 9 /14/20 18

1

40 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:249 0 9 -726 -25

1 in 1 CARTON

0 9 /14/20 18

2

25 g in 1 TUBE; 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 9 /14/20 18

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 -726 ) , label(249 0 9 -726 )

Revised: 3/2019

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