CBDMEDIC FOOT PAIN RELIEF- camphor and menthol. stick
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 Foot Pain Relief

Active Ingredients and Purpose

Camphor 10%, Menthol 15% (External Analgesics)

Uses

Temporarily relieves minor aches and pains of muscles and joints in the feet, toes and ankles.

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: rub solid stick 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 oil, peppermint oil, shea butter, sorbic acid, tea tree oil

PRINCIPAL DISPLAY PANEL

Active stick

CBDMEDIC FOOT PAIN RELIEF
camphor and menthol. stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24909-738
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	100 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	150 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)
CLOVE OIL (UNII: 578389D6D0)
COTTONSEED OIL (UNII: H3E878020N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HEMP (UNII: TD1MUT01Q7)
JOJOBA OIL (UNII: 724GKU717M)
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
SORBIC ACID (UNII: X045WJ989B)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24909-738-30	1 in 1 CARTON	03/06/2019
1		30 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/06/2019

Labeler - AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC (018950611)

Name	Address	ID/FEI	Business Operations
Establishment
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-738) , label(24909-738)