Tetragel Punch Topical Analgesic Gel

Tetragel Punch Topical Analgesic by

Drug Labeling and Warnings

Tetragel Punch Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Unit Dose, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TETRAGEL PUNCH TOPICAL ANALGESIC- tetracaine gel 
Unit Dose, 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.

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Tetragel Punch Topical Analgesic Gel

Drug Facts

Active Ingredient

​Tetracaine 2% w/w

Purpose

​External Local Anesthetic

Uses:

​External Use only Broken ​Skin. Temporarily relieves local discomfort or pain  ​from minor cuts, scrapes or abrasions.

Warnings

Do not use if you have

  • A know allergy or sensitivity to any of the ingredients.
  • Have a history of severe liver disease or impairment

When using this product

  • You may not have pain - Avoid sources of heat or injury
  • You may have burning or stinging if accidental eye contact
  • You mat have temporary skin irritation or sensitivity

Keep out of eyes and mouth. Keep out of reach of children.

Do not use if pregnant or breast feeding.

If accidentally swallowed get medical help right away. Not for chronic use.

Directions

Dab 1-2 gram to affected area as needed for telief. May repeat as needed up to four times per day. Use eyewash if accidental direct contact with eyes. Discontinue use if you have any undesired effect such as rash or irritation of treated area.

Other Information

Store in a cool dark place or refrigerate.

Inactive Ingredients:

DI Water, USP Glycerin, Methylcellulose

Preservatives: Chlorobutanol, Sodium Bisulfite, Sodium EDTA

Package Labeling:

Outer

TETRAGEL PUNCH TOPICAL ANALGESIC 
tetracaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67194-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV) TETRACAINE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67194-013-0130 g in 1 BOTTLE; Type 0: Not a Combination Product01/20/201601/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/20/201601/20/2017
Labeler - Unit Dose, Ltd. (119080393)

Revised: 2/2020
Document Id: 9e615d6b-1f49-23de-e053-2a95a90ac657
Set id: 6e0cd3a0-6b4d-4469-bb18-083cb1d7887a
Version: 4
Effective Time: 20200212
 
Unit Dose, Ltd.