KO PINK PAIN RELIEF CREAM- lidocaine hcl and phenolate sodium cream

KO Pink Pain Relief Cream by

Drug Labeling and Warnings

KO Pink Pain Relief Cream by is a Otc medication manufactured, distributed, or labeled by Remeverse, Lexia LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• apply a thin layer to affected area and massage until thoroughly absorbed into the skin
• apply every 6 to 8 hours, not to exceed 4 times daily
• wash hands with soap and water before and after use

Children 18 years or younger:

• Ask a doctor

Use

For the temporary relief of minor pain

Stop Use

Stop use and ask a doctor if

• condition worsens
• if rash appears
• symptoms persist for more than 7 days or clear up and occur again within a few days

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:

• In large quantities
• Over raw surfaces or blistered areas
• if you are allergic to ingredients in this product
• on puncture wounds
• Over large areas of the body

When using this product:

• use only as directed
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• avoid contact with eyes, lips and mouth
• do not apply to wounds, damaged, broken or irritated skin

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KO PINK PAIN RELIEF CREAM 
lidocaine hcl and phenolate sodium cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70317-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.04 g  in 1 mL
PHENOLATE SODIUM (UNII: 4NC0T56V35) (PHENOL - UNII:339NCG44TV)	PHENOLATE SODIUM	0.005 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
THIOCTIC ACID (UNII: 73Y7P0K73Y)
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)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CYANOCOBALAMIN (UNII: P6YC3EG204)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
BENFOTIAMINE (UNII: Y92OUS2H9B)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTONADIONE (UNII: A034SE7857)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70317-005-01	118 mL in 1 JAR; Type 0: Not a Combination Product	09/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/01/2023

Labeler - Remeverse (050186540)

Registrant - Lexia LLC (015552120)

Establishment
Name	Address	ID/FEI	Business Operations
Lexia LLC		015552120	manufacture(70317-005)