SUNMED PAIN FREEZE- menthol spray 
Sunflora 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.

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SUNMED pain spray Fast-Acting with MENTHOL

Menthol ................ 6%

Topical Analgesic

Temporary relief from minor aches and pains of muscles and joints associated with arthritis,simple backache,strains and sprains.

For external use only

When using this product • avoid contacts with the eyes Of mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days, or clear up and reoccur a gain within few days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions: Adult 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 physician

Inactive ingredients /Joo Barbadensis Leaf Extract,Arcium Lappa Roof (Buroock) Extract, Amica Montana Flower Extract, Boswellia Carteni Resin Extract Calendu Officinalis Extract, Camellia Sinensis Leaf Extract,Camphor; CartJomer,FD&C Blue #1,FD&C Yellow #5,Glycenn,llex Paraguanensis (Mate) Leaf Extract oopropyf /Jcoh , oopropyf Myristafe,Melissa Officinalis (LemooBalm)Leaf Extract, Silica,T=heryf Acetate,Tnethanolamine,water,Whole Hemp Extract

Sunmed Pain-Freeze Gel with Menthol

SUNMED PAIN FREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73240-904
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73240-904-0189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/29/2023
Labeler - Sunflora Inc. (067153368)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(73240-904)

Revised: 6/2023
Document Id: ff49699c-ceda-13d2-e053-6394a90af079
Set id: ff49699c-ced9-13d2-e053-6394a90af079
Version: 1
Effective Time: 20230629
 
Sunflora Inc.