Pain Relief Cream
FDA Label NDC 78149-205

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Qingdao Hainuo Biological Engineering Co., Ltd. for the product Pain Relief Cream (NDC 78149-205). 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 ingredient, purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 2%

Purpose

Topical analgesic

Use

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates,consult a doctor before use.

Do Not Use

  • Do not bandage tightly or aooly local heat (such as heating pads) to the aera of use.
  • Avoid contact with eyes or mucous membranes.
  • Do not apply to wounds or damaged broken or irritated skin.
  • Do not use at the same time as other topical analgesics.

Otc - When Using

Use only as directed.Read and follow all directions and warmings on this label.

If pregnant or breast-feeding,ask a health professional before use.

Otc - Stop Use

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Redness is present or irritation develops.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed,get medical help or contact a Poison Contriol Center right away.

Directions

  • For Use By Adults Only
  • Apply generously to affected area.
  • Massage into painful area until thoroughly absorbed into skin
  • Repeat as necessary.Repeat up 4 times a day.

* Please review the disclaimer below.