SUNMED PAIN FREEZE- menthol spray

SUNMED pain freeze by

Drug Labeling and Warnings

SUNMED pain freeze by is a Otc medication manufactured, distributed, or labeled by Sunflora Inc., Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

WARNINGS

For external use only

WHEN USING

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

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNMED PAIN FREEZE 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73240-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73240-904-01	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/29/2023

Labeler - Sunflora Inc. (067153368)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(73240-904)