SINSINPAS HOT- menthol,capsaicin patch

SINSINPAS HOT by

Drug Labeling and Warnings

SINSINPAS HOT by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 HOT PATCH

INGREDIENTS AND APPEARANCE

SINSINPAS HOT 
menthol,capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 17 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	8.3 mg  in 17 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-105-02	2 in 1 POUCH	08/01/2018
1	NDC: 55264-105-01	17 g in 1 PATCH; Type 0: Not a Combination Product

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	Business Operations
Sinsin Pharmaceutical Co., Ltd.		687867143	manufacture(55264-105)