SINSINPAS PAIN RELIEVING PATCH- dl-camphor, l-menthol, methyl salicylate patch

SINSINPAS Pain Relieving Patch by

Drug Labeling and Warnings

SINSINPAS Pain Relieving Patch 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

DL-Camphor (1.21%)

L-Menthol (5.54%)

Methyl Salicylate (6.11%)

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

Butylated Hydroxytoluene, Ester Gum, Natural Rubber, Polybutene, Polyisobutylene, Precipitated Calcium Carbonate, Quintone, Sorbitan Stearate, Tocopherol Acetate, YS Resin, Zinc Oxide

SINSINPAS Pain Relieving Patch

INGREDIENTS AND APPEARANCE

SINSINPAS PAIN RELIEVING PATCH 
dl-camphor, l-menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5.56 g  in 459.93 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	25.48 g  in 459.93 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	28.1 g  in 459.93 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ZINC OXIDE (UNII: SOI2LOH54Z)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
QUINONE (UNII: 3T006GV98U)
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-101-03	2 in 1 PACKAGE	05/01/2017
1	NDC: 55264-101-02	20 in 1 POUCH
1	NDC: 55264-101-01	459.93 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	05/01/2017

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(55264-101)