SINSINPAS AREXGEL: Package Insert and Label Information

SINSINPAS AREXGEL- camphor (synthetic), levomenthol and methyl salicylate patch
Sinsin Pharmaceutical Co., Ltd.

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.

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains

Warnings

For external use only


Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad
  • with, or at the same time as, other external analgesic products

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

  • do not use other than directed
  • avoid contact with eyes, mucous membranes, and rashes

Stop use and ask a doctor if

  • rash, itching, or excessive skin irritation develops
  • condition worsens
  • symptoms persist for longer than 7 days
  • symptoms clear up and reoccur within a few days

If pregnant or breast-feeding, ask a health professional before use.

Caution: This product contains natural rubber latex which may cause allergic reactions.

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:

  • Clean and dry affected area
  • Remove patch from film
  • Apply to affected area no more than 3 to 4 times daily for 7 days
  • Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Other Information

  • Avoid storing product in direct sunlight
  • Protect from excessive moisture

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

SINSINPAS AREX GEL PATCH

SINSINPAS AREX GEL PATCH
(click image for full-size original)

SINSINPAS AREXGEL
l-menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55264-114
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 96 mg
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 76.8 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 57.6 mg
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
NONIVAMIDE
SORBITOL
GELATIN
GLYCERYL MONOSTEARATE
EDETATE DISODIUM
ALUMINUM HYDROXIDE
KAOLIN
ALOE VERA LEAF
BUTYLATED HYDROXYTOLUENE
CASTOR OIL
WATER
TARTARIC ACID
TITANIUM DIOXIDE
METHYLPARABEN
POLYSORBATE 80
SODIUM POLYACRYLATE (8000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55264-114-02 1 PATCH in 1 POUCH contains a PATCH (55264-114-01)
1 NDC:55264-114-01 6 PATCH in 1 PATCH This package is contained within the POUCH (55264-114-02)
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 Operations
Sinsin Pharmaceutical Co., Ltd. 687867143 manufacture (55264-114)

Revised: 08/2021 Sinsin Pharmaceutical Co., Ltd.

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