OTC Medication Information: MENTHOL PAIN RELIEF Gel-Patch

MENTHOL PAIN RELIEF GEL-PATCH- menthol patch
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

Active Ingredient

Menthol 5.0%

Purpose

Topical Analgesic

Uses:

Temporary relief from minor aches and pains of sore muscles and joints

associated with: · arthrits · backache · strains · sprains

Warnings

For external use only

Ask a doctor before use if you have:

Sensitive skin

When using this product:

· Use only as directed · Do not bandage tightly or use with heating pad or device · 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 · Store in a cool dry place away from direct sunlight

Stop use and ask a doctor if:

Burning disconfort or excessive skin irritation develops, 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

· Adult and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

· Children under 12 years of age : Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water

Questions or Comments:

1 646-223-0128 · Lu.FDAmanage@gmail.com

· Store in a cool dry place away from direct sunlight

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MENTHOL PAIN RELIEF GEL-PATCH
menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73557-131
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.05 g in 1 g
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA FLOWER
FRANKINCENSE
KAOLIN
TARTARIC ACID
WATER
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
PROPYLENE GLYCOL
POLYACRYLIC ACID (250000 MW)
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM POLYACRYLATE (2500000 MW)
TITANIUM DIOXIDE
MINERAL OIL
PETROLATUM
HYDROXYACETOPHENONE
POLYSORBATE 80
GLYCERIN
POVIDONE K90
GREEN TEA LEAF
ALOE VERA LEAF
EDETATE DISODIUM
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73557-131-15 15 PATCH in 1 BOX contains a PATCH (73557-131-01)
1 NDC:73557-131-01 13 g in 1 PATCH This package is contained within the BOX (73557-131-15)
2 NDC:73557-131-16 15 PATCH in 1 BOX contains a PATCH (73557-131-02)
2 NDC:73557-131-02 11 g in 1 PATCH This package is contained within the BOX (73557-131-16)
3 NDC:73557-131-05 5 PATCH in 1 BOX contains a PATCH (73557-131-02)
3 NDC:73557-131-02 11 g in 1 PATCH This package is contained within the BOX (73557-131-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 01/09/2024
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 (73557-131), label (73557-131)

Revised: 02/2024 Shanghai Chuangshi Medical Technology (Group) 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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