KO Pink Pain Relief Cream

Manufacturer
Remeverse | Lexia LLC
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:49

Label at a glance#

ProductKO Pink Pain Relief Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, PHENOLATE SODIUM
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4.0%

Phenolate Sodium 0.5%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

For the temporary relief of minor pain

Stop Use

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - PURPOSE SECTION

For the relief of minor pain

Pregnant or Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding:

Ask a health professional before use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FrontFrontDrug FactsDrug Facts

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70317-005-012025-08-01C16284748780-13b156c62-3349-fb37-e063-e6dba90a4e07KO Pink Pain Relief Cream
70317-005-012025-07-29C16284748780-13b156c62-3349-fb37-e063-e6dba90a4e07KO Pink Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70317-005-01KO Pink Pain Relief Cream118 mL in 1 JARCREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70317-005KO PINK PAIN RELIEF CREAM (LIDOCAINE HCL AND PHENOLATE SODIUM) CREAM [REMEVERSE]21 package rows20241218_03110b38-0c53-17d6-e063-6394a90a7d86.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70317-00570317-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2969cf10-0887-53fe-e063-6394a90a599003110b38-0c53-17d6-e063-6394a90a7d862024-12-16WarningsExact identifier
spl id: 2969cf10-0887-53fe-e063-6394a90a5990
spl set id: 03110b38-0c53-17d6-e063-6394a90a7d86

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.