Label: AIR SINSIN PAS- camphor, menthol, methyl salicylate aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 55264-011-01 - Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Drug Label Information
Updated June 6, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
- 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 degrees F (48 degrees C).
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 analegic 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 membranes or rashes.
- do not bandage tightly.
- Directions
- Other information
- Inactive ingredients
- Manufactured by:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
AIR SINSIN PAS
camphor, menthol, methyl salicylate aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-011 Route of Administration TOPICAL, CUTANEOUS, TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.361 g in 100 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.289 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 0.361 g in 100 mL Inactive Ingredients Ingredient Name Strength DIPHENHYDRAMINE (UNII: 8GTS82S83M) THYMOL (UNII: 3J50XA376E) GLYCOL SALICYLATE (UNII: 3I1VBB7AXH) LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-011-01 200 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 07/01/2011 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