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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75249-004
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75249-004-01	100 g in 1 BOTTLE; Type 0: Not a Combination Product	07/21/2020	03/01/2023
2	NDC: 75249-004-02	1.9 g in 1 PACKET; Type 0: Not a Combination Product	07/21/2020	03/01/2023

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

Labeler - SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es kereskedelmi Korlatolt Felelossegu Tarsasag (401476254)

Name	Address	ID/FEI	Business Operations
Establishment
SOLITEINT Kozmetikum gyarto es forgalmazo termelo es kereskedelmi Korlatolt Felelossegu Tarsasag		401476254	manufacture(75249-004)

Revised: 12/2022

Document Id: f04b5bb1-4b0c-9501-e053-2995a90a72e6

Set id: d7c778cd-8eb2-566e-e053-2995a90a4195

Version: 2

Effective Time: 20221220

SOLITEINT Kozmetikum gyarto es forgalmazo, termelo es ker