Drug Facts

Composition & Product

Active Ingredients

Allantoin (0.5 g) Menthol (0.15 g)

Inactive Ingredients

Bentonite Cottonseed Oil Eucalyptus Oil Jojoba Oil Magnesium Oxide Peppermint Oil Silver Oxide White Wax Zinc Oxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-07-16

Medication Information

Purpose

Allantoin - Skin Protectant

Menthol - Topical Anesthetic

Description

Allantoin 0.5%, Menthol 0.15%

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 0.5%, Menthol 0.15%

Inactive Ingredients

bentonite, cera alba (organic beeswax), cotton seed oil, 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

Menthol - 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 0.5%, Menthol 0.15%

Inactive Ingredients

bentonite, cera alba (organic beeswax), cotton seed oil, 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

[{"name": "Allantoin", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENTONITE", "unii": "A3N5ZCN45C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COTTONSEED OIL", "unii": "H3E878020N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM OXIDE", "unii": "3A3U0GI71G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILVER OXIDE", "unii": "897WUN6G6T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 Menthol - 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 0.5%, Menthol 0.15%", "Inactive Ingredients": "bentonite, cera alba (organic beeswax), cotton seed oil, 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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information