Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cef12200-923c-49b2-ab11-ec7d9d0e10d8
Route
TOPICAL
Published
Effective Date 2014-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.5 g)
Inactive Ingredients
Bentonite Eucalyptus Oil Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide White Wax Zinc Oxide Coconut Oil Glycerin Lauric Acid Lavender Oil Olive Oil Palm Acid Palm Kernel Acid Pentasodium Pentetate Propylene Glycol Sodium Stearate Shea Butter Sodium Laureth Sulfate Stearic Acid Sodium Chloride Sodium Palmate Sodium Palm Kernelate Sorbitol Titanium Dioxide Etidronate Tetrasodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-18

Description

Allantoin 0.5%, Lidocaine HCL 0.5%

Purpose

Allantoin - Skin Protectant Lidocaine HCL - Topical Anesthetic


Medication Information

Purpose

Allantoin - Skin Protectant

Lidocaine HCL - Topical Anesthetic

Description

Allantoin 0.5%, Lidocaine HCL 0.5%

Uses

For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

Warnings

For external use only. Avoid contact with eyes. Do not apply to open wounds

or damaged skin. If symptoms persist for more than seven days, discontinue use and

consult physician.

If pregnant or breast feeding, contact physician prior to use.

Directions

Ointment: Apply directly to affected area. Do not use more than four

times per day. Store at room temperature. May stain fabrics.

Cleansing Bar: Wash affected area daily.

Active Ingredients

Allantoin 0.5%, Lidocaine HCL 0.5%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, eucalyptus oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box

Itch, Rash & Pain

  • Penetrating Pain and Intense Itching
  • Eczema, Dermatitis, Insect Bites
  • Rashes and Red Irritated Skin

All Natural

terrasil

ITCH, RASH & PAIN RELIEF OINTMENT

Plus Medicated Cleansing Bar

FAST & EFFECTIVE

itch and pain relief

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Keep Out of Reach of Children.

If swallowed, consult physician.


Structured Label Content

Uses

For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.

Purpose

Allantoin - Skin Protectant

Lidocaine HCL - Topical Anesthetic

Warnings

For external use only. Avoid contact with eyes. Do not apply to open wounds

or damaged skin. If symptoms persist for more than seven days, discontinue use and

consult physician.

If pregnant or breast feeding, contact physician prior to use.

Directions

Ointment: Apply directly to affected area. Do not use more than four

times per day. Store at room temperature. May stain fabrics.

Cleansing Bar: Wash affected area daily.

Active Ingredients

Allantoin 0.5%, Lidocaine HCL 0.5%

Inactive Ingredients

Ointment: beeswax (organic), bentonite (volcanic clay), eucalyptus citriodora oil, jojoba seed oil, magnesium oxide, peppermint oil, silver oxide, zinc oxide.

Cleansing Bar: beeswax, bentonite clay, coconut oil, eucalyptus oil, glycerin, jojoba seed oil, lauric acid, lavender oil, magnesium oxide, olive oil, palm acid, palm kernel acid, pentasodium pentetate, peppermint oil, propylene glycol, purified water, silver oxide, sodium stearate, sorbitol, shea butter, sodium laureth sulphate (SLES), stearic acid, sodium chloride, sodium palmate, sodium palm kernelate, sorbitol, titanium dioxide, tetrasodium etidronate, zinc oxide.

Principal Display Panel Box (PRINCIPAL DISPLAY PANEL - BOX)

Itch, Rash & Pain

  • Penetrating Pain and Intense Itching
  • Eczema, Dermatitis, Insect Bites
  • Rashes and Red Irritated Skin

All Natural

terrasil

ITCH, RASH & PAIN RELIEF OINTMENT

Plus Medicated Cleansing Bar

FAST & EFFECTIVE

itch and pain relief

THE END OF SUFFERING SKIN

Healing and Relief Since 2004

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, consult physician.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)