PAIN RELIEF Gel-Tube: Package Insert and Label Information

PAIN RELIEF GEL-TUBE- menthol gel
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Menthol 4.0% w/w …… Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Ask a doctor before use if you have

Sensitive skin

When using this product

Use only as directed • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

• Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Do not bandage or use with heating pad or device

Stop use and ask a doctor if

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breast-feeding

Ask a health professional before use

Keep out of reach of children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; message not necessary

Children under 12 years of age: Consult physician

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Questions or Comments

86-21-31166566

PAIN RELIEF GEL-TUBE menthol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73557-323 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.04 g in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL 95% TROLAMINE WATER SILICON DIOXIDE ILEX PARAGUARIENSIS LEAF ISOPROPYL MYRISTATE .ALPHA.-TOCOPHEROL, D- ALOE VERA LEAF GLYCERIN FD&C YELLOW NO. 5 FD&C BLUE NO. 1 GREEN TEA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE FRANKINCENSE ARNICA MONTANA FLOWER CAMPHOR (SYNTHETIC)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73557-323-30 89 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/28/2022

Labeler — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Registrant — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture (73557-323), label (73557-323)

Revised: 12/2022 Shanghai Chuangshi Medical Technology (Group) Co., Ltd.