Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 36224557-ea12-441e-b11d-ef70070826f2
Route
TOPICAL
Published
Effective Date 2012-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1 g) Lidocaine
Inactive Ingredients
Bentonite Eucalyptus Oil Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-07

Description

Allantoin 1%, Lidocaine HCL 1%

Purpose

Allantoin - Skin Protectant Lidocaine HCL - Topical Anesthetic


Medication Information

Purpose

Allantoin - Skin Protectant

Lidocaine HCL - Topical Anesthetic

Description

Allantoin 1%, Lidocaine HCL 1%

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 swallowed, consult physician. Do not bandage tightly.

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

Directions

Apply directly to effected area. Do not use more than four

times per day. Store at room temperature.

Active Ingredients

Allantoin 1%, Lidocaine HCL 1%

Inactive Ingredients

(Organic) Beeswax, Bentonite, Eucalyptus Citriodora Oil, Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil,

Zinc Oxide.

Keep Out of Reach of Children.

If swallowed, consult physician.

Principal Display Panel 44g Label


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 swallowed, consult physician. Do not bandage tightly.

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

Directions

Apply directly to effected area. Do not use more than four

times per day. Store at room temperature.

Active Ingredients

Allantoin 1%, Lidocaine HCL 1%

Inactive Ingredients

(Organic) Beeswax, Bentonite, Eucalyptus Citriodora Oil, Magnesium Oxide, Peppermint Oil, Silver Oxide, Simmondsia Chinensis (Jojoba) Seed Oil,

Zinc Oxide.

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

If swallowed, consult physician.

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


Advanced Ingredient Data


Raw Label Data

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