TERRASIL BOIL PAIN RELIEF- benzocaine ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Benzocaine 3.5%

Purpose

Pain Reliever

Uses

For the temporary relief of pain and discomfort caused by boils.

Warnings

For external use only. Do not use for more than 3 days. Ask a doctor before use if you have boils on the lips, nose, cheeks, or forehead. When using this product avoid contact with the eyes. Stop use and ask a doctor if - fever occurs, - redness around the boil develops, - condition worsens or does not improve, - symptoms persist for more than 3 days, - symptoms clear up and occur again within a few days.

Keep out of reach of children.

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

Directions

Adults and children 2 years of age and older: Apply to affected area no more than 2 times daily. Children under 2 years of age: Consult a doctor. Store at room temperature. May stain fabrics.

Inactive Ingredients

beeswax (organic), bentonite (volcanic clay), jojoba seed oil, magnesium oxide, silver oxide, tea tree oil, turmeric, zinc oxide.

PRINCIPAL DISPLAY PANEL - 44g Label

terrasil with Activated Minerals

Boil Pain Relief
Fast. Powerful. Relief.

INGREDIENTS AND APPEARANCE

TERRASIL BOIL PAIN RELIEF 
benzocaine ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
SILVER OXIDE (UNII: 897WUN6G6T)
TEA TREE OIL (UNII: VIF565UC2G)
TURMERIC (UNII: 856YO1Z64F)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-120-14	14 g in 1 JAR
2	NDC: 24909-120-44	44 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/20/2014

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-120) , label(24909-120)