FDA Label for Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving

View Indications, Usage & Precautions

Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients

Lidocaine hydrochloride 4%


Otc - Purpose



Purpose

Lidocaine hydrochloride - Topical analgesic


Indications & Usage



Uses

For temporary relief of pain and itching


Warnings



Warnings

For external use only

Flammable: Keep away from fire and flame


Otc - Do Not Use



Do not use in large quantities, particularly over raw surfaces or blistered areas


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • a rash or irritation develops

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
  • children under 12 years of age: do not use, ask a doctor

Other Safety Information



Other information

  • avoid storing in direct sunlight
  • store with lid tightly closed

Inactive Ingredient



Inactive ingredients alcohol, propylene glycol, sodium hydroxide, water


Package Label.Principal Display Panel




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