MELT PAIN AWAY- capsaicin cream 
Proximity Capital Partners LLC dba Asutra

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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Melt Pain Away (Asutra)

Capsaicin .025%

Topical Analgesic

Temporarily relieves minor aches and pains of muscles and joints associated with:

Use only as directed.

For external use only.

When using this product:

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask doctor if:

  • condition worsens
  • symptoms persist for more than 7 days, or clear up and reoccur again with a few days
  • redness is present
  • irritation develops.

If pregnant or breastfeeding, ask a health professional before use.

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

Adults and children over 18 years:

times daily.

Children 18 years and younger:

Water, Magnesium Chloride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Dimethyl Sulfone (MSM), Sodium Lactate, Glyceryl Stearate Citrate, Cetyl Palmitate, Glycerin, Glyceryl Stearate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Undecane, Xanthan Gum, Magnesium Sulfate, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate (Vitamin E), Hydroxyacetophenone, Panthenol, Allantoin, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil* *Organic

888-819-6472; Monday–Friday, 9am–5pm CT
Report any serious side effects to number above.

Melt Pain Away

MELT PAIN AWAY 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72683-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CYMBOPOGON FLEXUOSUS LEAF (UNII: 7LJ4Y1UJG7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
UNDECANE (UNII: JV0QT00NUE)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIDECANE (UNII: A3LZF0L939)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALMOND OIL (UNII: 66YXD4DKO9)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALLANTOIN (UNII: 344S277G0Z)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72683-003-01200 g in 1 JAR; Type 0: Not a Combination Product04/15/2020
2NDC:72683-003-021.9 g in 1 PACKET; Type 0: Not a Combination Product04/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/15/2020
Labeler - Proximity Capital Partners LLC dba Asutra (081214985)
Establishment
NameAddressID/FEIBusiness Operations
SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(72683-003)

Revised: 4/2020
Document Id: a95a11d7-a2af-6654-e053-2a95a90a802c
Set id: a95a11d7-a2ae-6654-e053-2a95a90a802c
Version: 1
Effective Time: 20200415
 
Proximity Capital Partners LLC dba Asutra