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SPL v1

SPL

SPL Set ID 250cefe3-aaff-1d94-e063-6394a90ab6d1

Route

TOPICAL

Published

Effective Date 2024-10-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Xanthium Sibiricum Root (3 mg) Sunflower Oil (1.5 mg) Angelica Dahurica Root (1 mg)

Inactive Ingredients

Lanolin Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-10-22

Description

XANTHIUM SIBIRICUM ROOT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,ANGELICA DAHURICA ROOT EXTRACT

Purpose

Clear the nasal cavity and relieve nasal discomfort; remove foreign objects blocking the nasal cavity and make the nasal cavity clean and unobstructed; solve acute and chronic rhinitis.

Medication Information

Purpose

Clear the nasal cavity and relieve nasal discomfort; remove foreign objects blocking the nasal cavity and make the nasal cavity clean and unobstructed; solve acute and chronic rhinitis.

Description

XANTHIUM SIBIRICUM ROOT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,ANGELICA DAHURICA ROOT EXTRACT

Use

Apply an appropriate amount of this product to the affected area and wait for it to be absorbed.

Section 44425-7

Store in a cool and dry place.

Section 50565-1

Please keep out of reach of children. Do not swallow.

Section 51727-6

GLYCERIN,LANOLIN

Section 51945-4

Stop Use

Discontinue use if signs of irritation or rash occur.

Warnings

Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.

Do Not Use

Discontinue use if signs of irritation or rash occur.

Active Ingredients

XANTHIUM SIBIRICUM ROOT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,ANGELICA DAHURICA ROOT EXTRACT

Structured Label Content

Use (use)

Apply an appropriate amount of this product to the affected area and wait for it to be absorbed.

Section 44425-7 (44425-7)

Store in a cool and dry place.

Section 50565-1 (50565-1)

Please keep out of reach of children. Do not swallow.

Section 51727-6 (51727-6)

GLYCERIN,LANOLIN

Section 51945-4 (51945-4)

Purpose (purpose)

Clear the nasal cavity and relieve nasal discomfort; remove foreign objects blocking the nasal cavity and make the nasal cavity clean and unobstructed; solve acute and chronic rhinitis.

Stop Use (Stop use)

Discontinue use if signs of irritation or rash occur.

Warnings (WARNINGS)

Do Not Use (Do not use)

Discontinue use if signs of irritation or rash occur.

Active Ingredients (ACTIVE INGREDIENTS)

XANTHIUM SIBIRICUM ROOT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,ANGELICA DAHURICA ROOT EXTRACT

Advanced Ingredient Data

[{"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "XANTHIUM SIBIRICUM ROOT", "unii": "8555ORT735", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ANGELICA DAHURICA ROOT", "unii": "1V63N2S972", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"use": "Apply an appropriate amount of this product to the affected area and wait for it to be absorbed.", "44425-7": "Store in a cool and dry place.", "50565-1": "Please keep out of reach of children. Do not swallow.", "51727-6": "GLYCERIN,LANOLIN", "purpose": "Clear the nasal cavity and relieve nasal discomfort; remove foreign objects blocking the nasal cavity and make the nasal cavity clean and unobstructed; solve acute and chronic rhinitis.", "Stop use": "Discontinue use if signs of irritation or rash occur.", "WARNINGS": "Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.", "Do not use": "Discontinue use if signs of irritation or rash occur.", "ACTIVE INGREDIENTS": "XANTHIUM SIBIRICUM ROOT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,ANGELICA DAHURICA ROOT EXTRACT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:56.884147 · Updated: 2026-03-14T23:04:18.906870