CU PAIN AWAY PAIN RELIEF- menthol cream 
Canadian Unique Health Ltd.

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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CU Pain Away Pain Relief

Drug Facts

Active ingredient

Menthol 1.25%

Purpose

Counterirritant

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only. Avoid contact with the eyes and mucous membranes.

When using this product

  • use only as directed
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation of the skin develops                                                                                                                                                                           If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

Directions

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Consult a doctor

Other information

  • Store in a cool dry place
  • Protect from heat and light

Inactive ingredients

aloe (Aloe barbadensis) leaf juice, avocado (Persea gratissima) oil, caprylyl glycol, cetearyl alcohol, coco-caprylate, coconut (Cocos nucifera) oil, cupric oxide, disodium EDTA, isoamyl cocoate, isopropyl palmitate, jojoba (Simmondsia chinensis) seed oil, lavender (Lavandula angustifolia) oil, lemon (Citrus limon) oil, phenoxyethanol, polysorbate 60, silk amino acids, sodium lactate, stearic acid, tea tree (Melaleuca alternifolia) leaf oil, tocopherol

Questions or comments?

Call 1-844-893-3085 Monday through Friday, 9-5pm EST or visit www.canadianunique.com

Package Labeling:

Label

CU PAIN AWAY PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71304-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CUPRIC OXIDE (UNII: V1XJQ704R4)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ISOAMYL COCOATE (UNII: 14OG46E98E)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
JOJOBA OIL (UNII: 724GKU717M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL (UNII: I9GRO824LL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71304-001-001 in 1 BOX03/08/2017
150 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/08/2017
Labeler - Canadian Unique Health Ltd. (203413273)

Revised: 10/2019
Document Id: 94e0207c-69f8-1f5c-e053-2a95a90a4029
Set id: 4a3d65db-a12e-4f50-e054-00144ff8d46c
Version: 5
Effective Time: 20191014
 
Canadian Unique Health Ltd.