MELT PAIN AWAY- capsaicin cream

Melt Pain Away by

Drug Labeling and Warnings

Melt Pain Away by is a Otc medication manufactured, distributed, or labeled by Proximity Capital Partners LLC dba Asutra, SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Capsaicin .025%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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

• arthritis
• simple backache
• strains
• sprains
• bruises

WARNINGS

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.

DOSAGE & ADMINISTRATION

Adults and children over 18 years:

• Apply to affected area. Massage into the painful area until thoroughly absorbed. Repeat as necessary but no more than 3 to 4

times daily.

• Wash hands with soap and water after applying.

Children 18 years and younger:

• Consult a doctor.

STORAGE AND HANDLING

• Store in a cool, dry place.
• Keep away from excessive heat or flame.
• Tamper-evident for your protection. Use only if safety seal is intact
  

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MELT PAIN AWAY 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72683-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72683-003-01	200 g in 1 JAR; Type 0: Not a Combination Product	04/15/2020
2	NDC: 72683-003-02	1.9 g in 1 PACKET; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/15/2020

Labeler - Proximity Capital Partners LLC dba Asutra (081214985)

Establishment
Name	Address	ID/FEI	Business Operations
SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag		401476254	manufacture(72683-003)