drug facts

drug facts
SPL v1
SPL
SPL Set ID 7db6aa01-3d47-4aeb-bb09-3e8e81f58ff6
Route
topical
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Allantoin - Skin Protectant Menthol - Topical Anesthetic

Description

Allantoin 0.5%, Menthol 0.15%


Medication Information

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.

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

Directions

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

times per day. Store at room temperature.

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.

Description

Allantoin 0.5%, Menthol 0.15%

Active Ingredients

Allantoin 0.5%, Menthol 0.15%

Keep Out of Reach of Children.

If swallowed, consult physician.

Principal Display Panel 44g Label


Structured Label Content

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.

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

Directions

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

times per day. Store at room temperature.

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.

Active Ingredients

Allantoin 0.5%, Menthol 0.15%

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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