Label: AIR SINSINPAS-EX- l-menthol, methyl salicylate, dl-camphor spray
- NDC Code(s): 55264-102-01
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 20, 2019
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- Active ingredients
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.
• Do not store in direct sunlight. • Store in Room temperature (1~30℃
- Keep out of children
- Inactive ingredients
- AIR SINSINPAS-EX
INGREDIENTS AND APPEARANCE
l-menthol, methyl salicylate, dl-camphor spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 6.4 g in 200 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 3.5 g in 200 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 6 g in 200 mL Inactive Ingredients Ingredient Name Strength DIPHENHYDRAMINE (UNII: 8GTS82S83M) ALCOHOL (UNII: 3K9958V90M) LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-102-01 200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/22/2017 Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161) Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161) Establishment Name Address ID/FEI Business Operations Sinsin Pharmaceutical Co., Ltd. 687867143 manufacture(55264-102)