SINSINPAS HOT LARGE- capsaicin patch

SINSINPAS HOT LARGE by

Drug Labeling and Warnings

SINSINPAS HOT LARGE 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

Capsicum extract 0.025% as Capsaicin

Purpose

Topical Analgesic

Uses

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

• Simple backache
• Arthritis
• Strains
• Bruises
• Sprains

Warnings

For external use only

Do not use

• on wounds or damaged skin
• with a heating pad
• if you are allergic to any ingredients of this product

When using this product

• do not use otherwise than directed
• avoid contact with eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

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.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

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.

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
• Remove patch from skin after at most 8 hours’ application

Children under 12 years of age:consult a doctor

Other information

Other information

• avoid storing product in direct sunlight
• protect product from excessive moisture

Inactive Ingredients

butyl hydroxytoluene, glyceryl rosinate, isopropryl myristate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (YS resin), titanium oxide, zinc oxide

Distributed by:

SINSIN Pharm America

Brea, CA 92821

Principal Display Panel

INGREDIENTS AND APPEARANCE

SINSINPAS HOT LARGE 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	30 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)
POLYISOBUTYLENE (200000 MW) (UNII: Z6Y02I0591)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GLYCERYL ROSINATE (UNII: SD112V492J)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
CALCIUM CARBONATE (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-110-01	1 in 1 POUCH	06/29/2021
1		3 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 Drug	M017	06/29/2021

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(55264-110)