Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 30816167-0876-433f-8cae-c075bcc5c9d9
Route
TOPICAL
Published
Effective Date 2014-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (3.5 g)
Inactive Ingredients
Bentonite Jojoba Oil Magnesium Oxide Silver Oxide Tea Tree Oil Turmeric White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-20

Description

Benzocaine 3.5%

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Benzocaine 3.5%

Uses

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

Warnings

For external use only. D o 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.

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.

Active Ingredient

Benzocaine 3.5%

Inactive Ingredients

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

Keep Out of Reach of Children.

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

Principal Display Panel 44g Label

terrasil with Activated Minerals

Boil Pain Relief

Fast. Powerful. Relief.


Structured Label Content

Uses

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

Purpose

Pain Reliever

Warnings

For external use only. D o 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.

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.

Active Ingredient

Benzocaine 3.5%

Inactive Ingredients

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

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.

Principal Display Panel 44g Label (PRINCIPAL DISPLAY PANEL - 44g Label)

terrasil with Activated Minerals

Boil Pain Relief

Fast. Powerful. Relief.


Advanced Ingredient Data


Raw Label Data

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