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Oxalis 20%

Oxalis 20%

Approved
Approval ID

3b52ff8d-4b87-d598-e063-6294a90aebd0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Uriel Pharmcy, Inc

DUNS: 043471163

Products 1

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

Oxalis 20%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-7221
Product Classification
G
Generic Name
Oxalis 20%
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (6)

LANOLIN ALCOHOLInactive
Code: 884C3FA9HE
Classification: IACT
OXALIS STRICTA WHOLEActive
Quantity: 1 [hp_X] in 1 g
Code: 3STW243384
Classification: ACTIB
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

Oxalis 20 Ointment

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active Ingredient: 100 gm contains: 40 gm Oxalis (Wood
sorrel) 1X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive Ingredients: Lanolin anhydrous, Sunflower seed oil, Beeswax, Lanolin alcohol, Xanthan gum

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

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

Use: Temporary relief of cramps.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/1/2025

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
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Oxalis 20% - FDA Drug Approval Details