MedPath

Norms Medicated Wipes

Norms Medicated Wipe™

Approved
Approval ID

3a78e109-3f7c-fb19-e063-6394a90ae78e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Totally Normal Company

DUNS: 138411054

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

witch hazel

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85996-001
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
witch hazel
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (10)

COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WITCH HAZELActive
Quantity: 0.5 g in 1 g
Code: 101I4J0U34
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/6/2025

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Norms™
It’s totally normal
75% of Americans experience hemorrhoids.
48 Medicated Wipes
For Hemorrhoid Wipes and Vaginal Care
6 x 5 IN. (15.2 x 12.7 CM)
FLUSHABLE & SEPTIC SAFE

LABELLABEL

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/6/2025

Uses

  • helps relieve the itching and discomfort associated with hemorrhoids
  • temporarily relief of irritation and burning
  • aids in protecting irritated anorectal areas

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/6/2025

Active ingredient

Witch hazel, 50%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/6/2025

Purpose

Astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 8/6/2025

Warnings

For external use only

  • 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

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

If pregnant or breastfeeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/6/2025

Keep out of reach of children

Keep out of reach of children- If swallowed, seek medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/6/2025

Directions

  • Adults: open the lid on the top of the wipes pouch.
  • Grab the top wipe at the edge of the centerfold and pull out of the pouch.
  • Use the wipe to clean the affected area by gently wiping, patting, or blotting.
  • If necessary, repeat until the area is clean. Dispose of the wipe in the trash; do not flush.
  • Use up to 6 times daily, or after each bowel movement, and before applying topical hemorrhoidal treatments.
  • Children under 12 years of age: Consult your pediatrician

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/6/2025

Inactive ingredients

Aloe Barbadensis Leaf Juice, Citric Acid, Cocamidopropyl Betaine, Diazolidinyl Urea, Glycerin, Methylparaben, Propylene Glycol, Sodium Citrate, Water

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/6/2025

Other information

  • Store at room temperature
  • Flush one wipe at the time for best results

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