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.

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.