PURA

Manufacturer
Mypura.com Limited
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:20:13

Label at a glance#

ProductPURA
Active ingredientWITCH HAZEL
Label structure11 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemmorhoids temporary relief of irritation and burning aids in protecting irritated anorectal areas

Dosage and administration

adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area. use upto 6 times daily or after each bowel movement and before applying hemmorhoidal treatments and then discard. children under 12 years of age consult a doctor Flush or dispose of wipe in thrash For best results flush no more than one wipe at a time

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemmorhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use upto 6 times daily or after each bowel movement and before applying hemmorhoidal treatments and then discard.
  • children under 12 years of age consult a doctor
  • Flush or dispose of wipe in thrash
  • For best results flush no more than one wipe at a time

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, citric acid, cocos nucifera (coconut) fruit oil, decyl glucoside, glycerin, phenoxythanol, potassium sorbate, sodium benzoate, water.

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20 - 25 ºC (68 - 77ºF)
  • for vaginal care- cleanse the area by gently wiping, patting or blotting. Repeat as needed
  • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutesand repeat as needed.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pura

48 medicated hemmorhoidal wipes

made from biodegradable plant fibers

Cooling and soothing Witch hazel

100% plastic-free flushable wipes

Pura's Pledge

We believe that you shouldn't have to choose between caring for your famile and caring for the environment. That's why we are on a mission to only create products that are good for people and planets.

48 WIPES - 7.7 X 6.3 IN

(195 X 160 MM)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN3
844379witch hazel 500 MG/ML Medicated PadSCD3
844379witch hazel 50 % Medicated PadSY3
844379witch hazel 50 % Medicated WipesSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84217-050-48PURA48 in 1 BOXCLOTH483
84217-050-48PURA1 in 1 PATCHCLOTH13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84217-05084217-050-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
ndc (package): 84217-050-48
ndc (product): 84217-050
ndc11 (package): 84217005048
spl id: 453a5aea-e8d8-e6f9-e063-6294a90a9ad9
spl set id: 1523f52f-6a5b-a12d-e063-6294a90a4496

Reported adverse events (FAERS/openFDA)#

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