Label: SINSINPAS AREXLOTION- l-menthol lotion
- NDC Code(s): 55264-112-01, 55264-112-02
- Packager: Sinsin Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
allergy alert: If prone to allergic reaction from aspirin or salicylates or allergic to any ingredients in this product, consult a doctor before use.
When using this product
- use only as directed
- avoid contact with eyes and mucous membranes or rashes
- rare cases of serious burns have been reported with products of this type
- do not apply to wounds or damaged, broken irritated skin
- do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
- do not use at the same time as other topical analgesics
- a transient burning sensation may occur upon application but generally disappears in several days
- if severe burning sensation occurs, discontinue use immediately
- do not expose the area treated with product to heat or direct sunlight
- avoid applying into skin folds
stop use and ask a doctor if
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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
- Directions
- Other Information
- Inactive Ingredients
- SINSINPAS AREX LOTION
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INGREDIENTS AND APPEARANCE
SINSINPAS AREXLOTION
l-menthol lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 200 mg ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE 1 mg LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 60 mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 60 (UNII: CAL22UVI4M) LANOLIN OIL (UNII: OVV5IIJ58F) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TROLAMINE (UNII: 9O3K93S3TK) CITRUS JUNOS FRUIT (UNII: 53KHW58C1V) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) LIGHT MINERAL OIL (UNII: N6K5787QVP) NONIVAMIDE (UNII: S846B891OR) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55264-112-02 1 in 1 BOX 08/27/2021 1 NDC:55264-112-01 1 in 1 BOTTLE; 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 08/27/2021 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(55264-112)