ALLEVIATE- menthol ointment

Alleviate by

Drug Labeling and Warnings

Alleviate by is a Otc medication manufactured, distributed, or labeled by Naticura Inc., Vegewax Caldeworx Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 0.57%

Purpose

Analgesic/Anesthetic/Antipruritic

Uses

• For the temporary relief of anorectal itching and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles (hemorrhoids)
• For the temporary relief of pain and burning.
• Can help distract from pain
• May provide a cooling sensation

Warnings

For external use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product

Stop use and ask a doctor if:

• condition worsens or does not improve within 7 days
• rectal bleeding occurs
• an allergic reaction develops
• the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad.
• Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
• Apply externally to the affected area up to 6 times daily.
• Children under 12 years of age: consult a doctor

Other information

• Keep at room temperature, 59 - 82°F
• Do not use if safety seal is broken

Inactive ingredients:

Beeswax, Cocoa Nut Butter, Coconut oil, Calendula Flower Essential Oil, Cypress Leaf Essential Oil, Geranium Flower Essential Oil, Jojoba Oil, Olive Oil, Peppermint flower Essential Oil, Shea Nut Butter

Questions or Comments:

Call weekdays 9 AM to 5 PM EST 1-866-984-5911

DOSAGE & ADMINISTRATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLEVIATE 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71453-288
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	275 mg  in 48.2 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
SHEA BUTTER (UNII: K49155WL9Y)
COCONUT OIL (UNII: Q9L0O73W7L)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
JOJOBA OIL (UNII: 724GKU717M)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71453-288-50	1 in 1 BOX	04/01/2018
1		48.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/01/2018

Labeler - Naticura Inc. (203502570)