FDA.reportPublic FDA data

AIR SINSINPAS-EX

Manufacturer
Sinsin Pharmaceutical Co., Ltd.
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:45

Label at a glance#

ProductAIR SINSINPAS-EX
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC), LEVOMENTHOL
Label structure8 sections

Indications and uses

For temporary relief of minor aches & pains of muscles & joints associated with: - arthritis - muscular pains - strains - bruises - sprains

Dosage and administration

• Adults and children 12 years of age and over : Clean and dry affected area. Shake the can before use. Spray onto affected area no longer than 3 seconds. Do not use more than 5 times daily for not more than 7 days. • Children under 12 years of age : Consult with a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

L-menthol (5.48g/100g)

Methyl Salicylate (2.99g/100g)

Dl-Camphor (5.20g/100g)

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

- arthritis

- muscular pains

- strains

- bruises

- sprains

Warnings

WARNINGS SECTION

For external use only • Avoid inhalation. • Do not use in a confined space. • Keep away from fire or flame. • Contents under pressure. • Do not puncture or incinerate container. • Do not expose to temperature exceeding 120 ℉(48 ℃)

Do not use on wounds or damaged skin. • if you are allergic to aspirin or salicylates. • with a heating pad. with, or at the same times as, other external analgesic products. • if you are allergic to any ingredients of this product.

When using this product
• do not use otherwise than as directed. • avoid contact with the eyes, mucous mem-branes or rashes. • do not bandage tightly.

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.

Other information

• Do not store in direct sunlight. • Store in Room temperature (1~30℃

Keep out of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and over : Clean and dry affected area. Shake the can before use. Spray onto affected area no longer than 3 seconds. Do not use more than 5 times daily for not more than 7 days.
• Children under 12 years of age : Consult with a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Diphenhydramine, Ethanol, Liquefied Petroleum Gas

AIR SINSINPAS-EX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

air sinsinpas exair sinsinpas ex

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55264-102-01AIR SINSINPAS-EX200 mL in 1 BOTTLE, SPRAYSPRAY2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55264-102AIR SINSINPAS-EX (L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR) SPRAY [SINSIN PHARMACEUTICAL CO., LTD.]4Legacy NDC, 1 package rows20240106_575c7c54-a539-57b1-e053-2991aa0a39c0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55264-10255264-102-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
DIPHENHYDRAMINE8GTS82S83MIACT
ALCOHOL3K9958V90MIACT
LIQUEFIED PETROLEUM GAS5K616HU99VIACT
LEVOMENTHOLBZ1R15MTK7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0e3c635a-adb8-f966-e063-6294a90aedb6575c7c54-a539-57b1-e053-2991aa0a39c02024-01-05WarningsExact identifier
spl id: 0e3c635a-adb8-f966-e063-6294a90aedb6
spl set id: 575c7c54-a539-57b1-e053-2991aa0a39c0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.