Ginsenggo
FDA Label NDC 55264-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sinsin Pharmaceutical Co., Ltd. for the product Ginsenggo (NDC 55264-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

DL-Camphor 0.70%

L-Menthol 1.40%

Methyl Salicylate 2.80%

Purpose

Topical Analgesic

Uses

for temporary relief of minor pain associated with:

  • Arthritis
  • Simple backache
  • Tendonitis
  • Muscle strains
  • Muscle sprains
  • Bruises

Warnings

For external use only.

  • If pregnant or breast feeding, consult a healthcare professional.
  • Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.

Do Not Use

  • on wounds or damaged skin
  • with, or at the same time as, other external analgesic products.

When Using This Product

  • use only as directed
  • do not bandage tightly or use with heating pad.
  • avoid contact with the eyes and mucous membranes.

Stop Use And Ask A Doctor If

  • conditions worsens.
  • symptoms persist more than 7 days or clear up and occur again within a few days.
  • rash, itiching, or excessive irritation develops.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older
  • clean and dry affected area
  • remove patch from film.
  • apply to affected area not more than 3 to 4 times daily for 7 days.
    • Children under 12 years of age consult a doctor
    Reseal pouch containing used portion patched

Other Information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive Ingredients

Butylated Hydroxy Toluene, Butyl Paraben, Carboxymethylcellulose sodium, Castor Oil, Concentrated Glycerin, D-Sorbitol Solution, Disodium Edetate, Gelatin, Kaolin, Magnesium Aluminometasilicate, Methyl paraben, Phellodendron Bark Extract, Polyethylene glycol Monostearate, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Tartaric acid

How To Apply

1. Pull off printed paper

2. Peel off protective film

3. Gently apply medicated pad in the affected area

4. Pull off the remaining paper

Manufactured By:

SINSIN PHARM. CO., LTD.

http://www.sinsin.com    tel: 82-31-776-1140~3

776-6, Wonsi-Dong, Danwon-Gu, Ansan City, Kyunggi-Do, Korea

Made in Korea

Principal Display Panel

Ginsenggo Front DisplayGinsenggo Back Display

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