PAIN RELIEF- menthol spray 
Sagely Enterprises Inc.

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.

----------

Pain Relief Spray

Active ingredient

Menthol 10%

Purpose

Menthol 10%...................Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Do not use

  • on wounds or damaged, broken, or irritated skin
  • with a heating pad

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding, 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

Inactive ingredients

SD Alcohol 40-B, Water, Sambucus Nigra Fruit Extract, Boswellia Serrata Extract, Camphor, Mentha Piperita Oil, Glycerin, Arnica Montana Flower Extract

Sagely Naturals

Extra Strength

Pain Relief Spray

95% Natural Ingredients

Instant Cooling

with 10% Menthol

2 Fl Oz / 60 mL

1

2

PAIN RELIEF 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82075-430
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82075-430-301 in 1 CARTON11/19/2021
160 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/19/2021
Labeler - Sagely Enterprises Inc. (117049032)
Establishment
NameAddressID/FEIBusiness Operations
PakLab078717086manufacture(82075-430)

Revised: 12/2021
Document Id: d245c518-1ce5-107b-e053-2a95a90a7729
Set id: d12a84cb-7211-1ccd-e053-2995a90a3d39
Version: 2
Effective Time: 20211203
 
Sagely Enterprises Inc.