OTC Medication Information: Pain Relief Cream

PAIN RELIEF CREAM- menthol solution
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredient

Menthol 2%

ARNICA MONTANA FLOWER extract,
ANGELICA SINENSIS ROOT extract,
papaya extract ,
Myrrh extract,
Heracleum hemsleyanum Diels extract,
HOMALOMENA OCCULTA ROOT extract,
Boswellia carterii Birdw extract, GLYCERIN, Caprylic capric triglycerride, Laurocapram, Squalane, Water

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.

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.

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.

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.

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PAIN RELIEF CREAM
pain relief cream solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78149-205
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA FLOWER
ANGELICA SINENSIS ROOT
PAPAYA
MYRRH
HERACLEUM HEMSLEYANUM WHOLE
HOMALOMENA OCCULTA ROOT
BOSWELLIA SACRA WHOLE
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
LAUROCAPRAM
SQUALANE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78149-205-01 1 BOTTLE in 1 PACKAGE contains a BOTTLE
1 100 g in 1 BOTTLE This package is contained within the PACKAGE (78149-205-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/06/2022
Labeler — QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD. (529667276)
Establishment
Name Address ID/FEI Operations
QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD. 529667276 manufacture (78149-205)

Revised: 09/2022 QINGDAO HAINUO BIOLOGICAL ENGINEERING CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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