FDA.reportPublic FDA data

Naticura Alleviate Natural Hemorrhoid Relief

Manufacturer
Vegewax Caldeworx Ltd
Effective date
2018-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:46:09

Label at a glance#

ProductNaticura Alleviate Natural Hemorrhoid Relief
Active ingredientMENTHOL
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.57%

Purpose

OTC - PURPOSE SECTION

Analgesic/Anesthetic/Antipruritic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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:

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alleviate BoxAlleviate Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44114-18344114-183-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
JOJOBA OIL724GKU717MIACT
OLIVE OIL6UYK2W1W1EIACT
MENTHOLL7T10EIP3AACTIB
YELLOW WAX2ZA36H0S2VIACT
COCOA BUTTER512OYT1CRRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7b08df3e-ee14-03d7-e053-2a91aa0a251b7b08df3e-ee13-03d7-e053-2a91aa0a251b2018-11-14WarningsExact identifier
spl id: 7b08df3e-ee14-03d7-e053-2a91aa0a251b
spl set id: 7b08df3e-ee13-03d7-e053-2a91aa0a251b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.