OTC Medication Information: SINSINPAS COLD

SINSINPAS COLD- menthol patch
Sinsin Pharmaceutical 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 Ingredients

L-Menthol (5%)

Purpose

Topical Analgesic

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with:

• Arthritis
• Simple backache
• Strains
• Bruises
• Sprains

Warnings

For external use only

Do not use

• on wounds or damaged skin
• if you are allergic to any ingredients of this product
• with a heating pad
• with, or at the same time as, other external analgesic products

When using this product

• do not use otherwise than directed
• avoid contact with eyes, mucous membranes or rashes
• do not bandage tightly

Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

Stop use and ask a doctor if

• rash, itching, or excessive skin irritation develops
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

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

Directions

Adults and children 12 years of age and over:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area no more than 3 to 4 times daily for 7 days
• Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Inactive Ingredients

Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.

SINSINPAS COLD PATCH

SINSINPAS COLD l-menthol patch

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-104 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 0.85 g in 17 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55264-104-02 2 PATCH in 1 POUCH contains a PATCH (55264-104-01) 1 NDC:55264-104-01 17 g in 1 PATCH This package is contained within the POUCH (55264-104-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/01/2018

Labeler — Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant — Sinsin Pharmaceutical Co., Ltd. (687867143)

Establishment
Name	Address	ID/FEI	Operations
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture (55264-104)

Revised: 11/2020 Sinsin Pharmaceutical Co., Ltd.