Chill Pain Away by Proximity Capital Partners LLC dba Asutra / SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag

Chill Pain Away by

Drug Labeling and Warnings

Chill 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]

CHILL 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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Actve Ingredients

Capsaicin...0.025%

Purpose

Topical Analgesic

Uses

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

· arthritis ·simple backache · strains · sprains · bruises

Use only as directed.

For external use only. Keep away from excessive heat or flame

when using this product

• avoid eye contact
• do not apply to wounds or damaged skin
• do no bandage tightly

Stop use and ask doctor if:

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

If pregnant or breast feeding, ask ahealth professional before use

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

Directions

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 doctor

Other Information

• Store in a cool, dry place.
• Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond
Oil), Butyrospermum Parkii (Shea Butter), Sodium Lactate, Glyceryl Stearate, Undecane, Polygyceryl-6 Palmitate/Succinate, Pentene Glycol, Xylitylglucoside, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Cetyl Palmitate, Cannabidiol Isolate, Anhydroxylitol, Xylitol, Cetearyl Alcohol, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Tridecane, Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Calcium Chloride, Ascorbyl Palmitate, Hydroxyacetophenone, Disodium EDTA

CHILL PAIN AWAY 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72683-004
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
UNDECANE (UNII: JV0QT00NUE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CANNABIDIOL (UNII: 19GBJ60SN5)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECANE (UNII: A3LZF0L939)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM LACTATE (UNII: TU7HW0W0QT)
POLYGLYCERYL-2 PALMITATE (UNII: V2A5PDC572)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72683-004-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020	03/01/2023
2	NDC: 72683-004-02	1.9 g in 1 PACKET; Type 0: Not a Combination Product	07/21/2020	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/21/2020	03/01/2023

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(72683-004)

Revised: 12/2022

Document Id: f04b502d-c92d-93c8-e053-2a95a90aa5e0

34390-5

Set id: aafaf563-3317-683d-e053-2a95a90a242c

Version: 2

Effective Time: 20221220

 

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