SINSINPAS AREXLOTION- l-menthol lotion

SINSINPAS AREXLOTION by

Drug Labeling and Warnings

SINSINPAS AREXLOTION by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Methyl Salicylate 200.0mg

L-Menthol 60.0mg

Tocopherol Acetate 1.0mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

• Arthritis
• Simple backache
• Muscle strains
• Sprains
• Bruises
• Cramps

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over:

• apply a thin layer to affected area
• massage into painful area until thoroughly absorbed into skin

repeat as necessary, but no more than 3 to 4 times daily

• AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

Children undress 12 years of age: ask a doctor

Other Information

• Avoid storing product in direct sunlight, store at 20-25C (68-77F)
• Store with lid closed tightly

Inactive Ingredients

Nonylic acid vanillyamide, Carbomer 941, Light liquid paraffin, Polysorbate 60, Sorbital Monostearate. Lanolin oil, Triethanolamine, Fresh yuja flavor, Purified water

SINSINPAS AREX LOTION

INGREDIENTS AND APPEARANCE

SINSINPAS AREXLOTION 
l-menthol lotion

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
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)