Naticura Alleviate Natural Hemorrhoid Relief

Naticura Alleviate Natural Hemorrhoid Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

NATICURA ALLEVIATE NATURAL HEMORRHOID RELIEF- menthol ointment 
Vegewax Caldeworx Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Naticura Alleviate Natural Hemorrhoid Relief

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

Alleviate Box

NATICURA ALLEVIATE NATURAL HEMORRHOID RELIEF 
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 44114-183
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL275 mg  in 48.2 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 44114-183-501 in 1 BOX04/01/2018
148.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2018
Labeler - Vegewax Caldeworx Ltd (201050882)
Registrant - Vegewax Caldeworx Ltd (201050882)

Revised: 11/2018
Document Id: 7b08df3e-ee14-03d7-e053-2a91aa0a251b
Set id: 7b08df3e-ee13-03d7-e053-2a91aa0a251b
Version: 1
Effective Time: 20181114
 
Vegewax Caldeworx Ltd