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
- 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.
Drug Label Information
Updated August 27, 2021
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- Official Label (Printer Friendly)
- Active Ingredients
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
- Other Information
- Inactive Ingredients
- SINSINPAS AREX LOTION
INGREDIENTS AND APPEARANCE
Product 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 LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 60 mg 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 Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) LIGHT MINERAL OIL (UNII: N6K5787QVP) NONIVAMIDE (UNII: S846B891OR) WATER (UNII: 059QF0KO0R) POLYSORBATE 60 (UNII: CAL22UVI4M) LANOLIN OIL (UNII: OVV5IIJ58F) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TROLAMINE (UNII: 9O3K93S3TK) CITRUS JUNOS FRUIT (UNII: 53KHW58C1V) 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 not final part348 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)