PENICHILLIN- tetracaine cream

PENICHILLIN by

Drug Labeling and Warnings

PENICHILLIN by is a Otc medication manufactured, distributed, or labeled by Sambria Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tetracaine 2%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching due to minor skin irritation.

Warnings

For external use only. Avoid contact with eyes. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center immediately.

Keep out of reach of children

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

Directions

For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily.

Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds.

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin,
Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol,
Polyacrylamide, Propylene Glycol,StearicAcid, Triethanolamine.

Other information

Protect this product from excessive heat and direct sun. Never tested on animals, just late clients.

Product label

INGREDIENTS AND APPEARANCE

PENICHILLIN 
tetracaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54723-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54723-014-01	3 mL in 1 PACKET; Type 0: Not a Combination Product	03/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/31/2023

Labeler - Sambria Pharmaceuticals, LLC (078676259)