Active Ingredients
Lidocaine Hydrochloride 4.0%
Phenolate Sodium 0.5%
Ko Pink Pain Relief Cream
FDA Label NDC 70317-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Remeverse for the product Ko Pink Pain Relief Cream (NDC 70317-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, directions, use, stop use, warning - keep out of reach of children, warnings, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- Ask a doctor
Children 18 years or younger:
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
- 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
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
* Please review the disclaimer below.
