Chill Pain Away by SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag / 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 SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag, 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 
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag

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

PDP

CHILL PAIN AWAY 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75249-004
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75249-004-01100 g in 1 BOTTLE; Type 0: Not a Combination Product07/21/202003/01/2023
2NDC: 75249-004-021.9 g in 1 PACKET; Type 0: Not a Combination Product07/21/202003/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/21/202003/01/2023
Labeler - SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag (401476254)
Establishment
NameAddressID/FEIBusiness Operations
SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag401476254manufacture(75249-004)

Revised: 12/2022
 
SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es ker

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