KO PINK PAIN RELIEF CREAM- lidocaine hcl and phenolate sodium cream 
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KO Pink Pain Relief Cream

Active Ingredients

Lidocaine Hydrochloride 4.0%

Phenolate Sodium 0.5%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Glycerin, Calendula Officinalis Flower Extract, Glyceryl Stearate, Sodium Hyaluronate, Butylene Glycol, Cetyl Alcohol, Sodium Hydroxide, Isonononyl Isononanoate, Stearic Acid, Thioctic Acid (Alpha Lipoic Acid) powder, Carbomer, Cetearyl 2-Ethylhexanoate, Dimethylsulfone (MSM), Polysorbate 80, Hydroxypropyl Methylcellulose, N-Acetyl Glucosamine, SYN-TC, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tocopheryl Acetate (Vitamin E), Phytonadione (Vitamin K), Benfotiamine, Curcumin, Ceramide 3, 3-glyceryl Ascorbate (Vitamin C), Pyridoxine Hydrochloride, Cyanocobalamin, Cyclodextrin, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol

Directions

Adults and children over 18 years:

Children 18 years or younger:

Use

For the temporary relief of minor pain

Stop Use

Stop use and ask a doctor if

Warning - Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

Do not use:

When using this product:

Storage

store out of direct light at room temperature, between 40F and 86F (4C and 30C)

do not use if protective seal on jar is torn broken or missing upon first use

Purpose

For the relief of minor pain

Pregnant or Breastfeeding

If pregnant or breast feeding:

Ask a health professional before use

FrontDrug Facts

KO PINK PAIN RELIEF CREAM 
lidocaine hcl and phenolate sodium cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70317-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 mL
PHENOLATE SODIUM (UNII: 4NC0T56V35) (PHENOL - UNII:339NCG44TV) PHENOLATE SODIUM0.005 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
N-ACETYLGLUCOSAMINE (UNII: V956696549)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
THIOCTIC ACID (UNII: 73Y7P0K73Y)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CYANOCOBALAMIN (UNII: P6YC3EG204)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PHYTONADIONE (UNII: A034SE7857)  
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
BENFOTIAMINE (UNII: Y92OUS2H9B)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
WATER (UNII: 059QF0KO0R)  
CURCUMIN (UNII: IT942ZTH98)  
3-GLYCERYL ASCORBATE (UNII: 3R1Q5X5GGO)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70317-005-01118 mL in 1 JAR; Type 0: Not a Combination Product09/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/01/2023
Labeler - Remeverse (050186540)
Registrant - Lexia LLC (015552120)
Establishment
NameAddressID/FEIBusiness Operations
Lexia LLC015552120manufacture(70317-005)

Revised: 8/2023
Document Id: 03110b38-0c54-17d6-e063-6394a90a7d86
Set id: 03110b38-0c53-17d6-e063-6394a90a7d86
Version: 1
Effective Time: 20230816
 
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