drug facts

drug facts

SPL v1

SPL

SPL Set ID 3af07373-2bbc-4428-bb63-4313dc1dd8b5

Route

topical

Published

Effective Date 2017-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

calendula officinalis flower (1 [hp_X]) comfrey (3 [hp_X]) thuja occidentalis whole

Inactive Ingredients

cottonseed oil honey jojoba oil magnesium oxide peppermint oil silver oxide tea tree oil white wax zinc oxide

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2017-06-01

Purpose

Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

Description

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Medication Information

Warnings

For external use only. Do not get into eyes.

Uses

Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

Purpose

Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

Directions

Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

Description

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Active Ingredient

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Keep Out of Reach of Children.

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

Principal Display Panel 50g Tube

Fastrin

Incontinence & Ostomy

Rash Care Ointment

Net WT 50g (1.76 oz.)

Structured Label Content

Warnings

For external use only. Do not get into eyes.

Uses

Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.

Purpose

Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief

Directions

Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.

Inactive Ingredients

Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide

Active Ingredient

Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel 50g Tube (PRINCIPAL DISPLAY PANEL - 50g Tube)

Fastrin

Incontinence & Ostomy

Rash Care Ointment

Net WT 50g (1.76 oz.)

Advanced Ingredient Data

[{"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "COMFREY", "unii": "D05HXK6R3G", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "THUJA OCCIDENTALIS WHOLE", "unii": "5HBV6WCE3N", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "COTTONSEED OIL", "unii": "H3E878020N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HONEY", "unii": "Y9H1V576FH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM OXIDE", "unii": "3A3U0GI71G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILVER OXIDE", "unii": "897WUN6G6T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps relieve and prevent rashes and irritation due to wetness from incontinence. Helps prevent infection.", "Purpose": "Calendula - Healing Agent, Comfrey - Anti-Inflammatory, Thuja - Irritation Relief", "Warnings": "For external use only. Do not get into eyes.", "Directions": "Clean and dry affected skin. Apply a thin layer of ointment over the affected area. Repeat 1 to 3 times daily or as needed.", "Active Ingredient": "Calendula officinalis 1X HPUS, Comfrey (Symphytum officinale) 1X HPUS, Thuja occidentalis 3X HPUS", "Inactive Ingredients": "Beeswax, Cottonseed Oil, Jojoba Seed Oil, Magnesium Oxide, Manuka Honey, Peppermint Oil, Silver Oxide, Tea Tree Oil, Zinc Oxide", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center immediately.", "PRINCIPAL DISPLAY PANEL - 50g Tube": "Fastrin Incontinence & Ostomy Rash Care Ointment Net WT 50g (1.76 oz.)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:43.846907 · Updated: 2026-03-14T23:14:41.895392