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SPL v2

SPL

SPL Set ID effc3327-df1b-0c9b-e053-2a95a90a4f29

Route

NASAL

Published

Effective Date 2023-01-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Goldenseal (4 [hp_X]) Lycopodium Clavatum Spore (3 [hp_X]) Ephedra Distachya Flowering Twig (8 [hp_X]) Daphne Mezereum Bark (10 [hp_X]) Kerosene Pulsatilla Vulgaris Thuja Occidentalis Leafy Twig

Inactive Ingredients

Water Hamamelis Virginiana Top Water Glycerin Thymol Hydrogen Peroxide Alcohol

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2023-01-02

Description

Hydrastis Canadensis 4xHPUS Lycopodium Clavatum 3xHPUS Ephedra Vulgaris 3xHPUS Mezereum 3xHPUS Petroleum 8xHPUS Pulsatilla 3xHPUS Thuja Occidentalis 10xHPUS The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

Medication Information

Warnings and Precautions

Do not spray in eyes, mouth or ears.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed, get medical help or contact Poison Control Center right away.

Indications and Usage

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

Dosage and Administration

Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

Description

Section 50565-1

Keep out of reach of children.

Section 51727-6

Aqua Demineralisata, Aqua Hamamelidis, Alcohol 7.7% by volume, Glycerin, Thymol, and Hydrogen Peroxide.

Section 51945-4

Section 55105-1

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

Section 55106-9

Hydrastis Canadensis 4xHPUS

Lycopodium Clavatum 3xHPUS

Ephedra Vulgaris 3xHPUS

Mezereum 3xHPUS

Petroleum 8xHPUS

Pulsatilla 3xHPUS

Thuja Occidentalis 10xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

Dosage and Administration (34068-7)

Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.

Warnings and Precautions (34071-1)

Do not spray in eyes, mouth or ears.

If pregnant or breast-feeding, ask a health professional before use.

If swallowed, get medical help or contact Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Aqua Demineralisata, Aqua Hamamelidis, Alcohol 7.7% by volume, Glycerin, Thymol, and Hydrogen Peroxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.

Section 55106-9 (55106-9)

Hydrastis Canadensis 4xHPUS

Lycopodium Clavatum 3xHPUS

Ephedra Vulgaris 3xHPUS

Mezereum 3xHPUS

Petroleum 8xHPUS

Pulsatilla 3xHPUS

Thuja Occidentalis 10xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States.

Advanced Ingredient Data

[{"name": "GOLDENSEAL", "unii": "ZW3Z11D0JV", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "EPHEDRA DISTACHYA FLOWERING TWIG", "unii": "R55VQ87DP3", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "DAPHNE MEZEREUM BARK", "unii": "X2N6E405GV", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "KEROSENE", "unii": "1C89KKC04E", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "PULSATILLA VULGARIS", "unii": "I76KB35JEV", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "THUJA OCCIDENTALIS LEAFY TWIG", "unii": "1NT28V9397", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HAMAMELIS VIRGINIANA TOP WATER", "unii": "NT00Y05A2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.", "34068-7": "Adults: 1-2 sprays in each nostril as needed. Wipe tip clean after use. Not intended for infants or small children.", "34071-1": "Do not spray in eyes, mouth or ears. If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact Poison Control Center right away.", "50565-1": "Keep out of reach of children.", "51727-6": "Aqua Demineralisata, Aqua Hamamelidis, Alcohol 7.7% by volume, Glycerin, Thymol, and Hydrogen Peroxide.", "55105-1": "For the temporary relief of sinus congestion due to colds and flu, hay fever, rhinitus, and nasal dryness.", "55106-9": "Hydrastis Canadensis 4xHPUS Lycopodium Clavatum 3xHPUS Ephedra Vulgaris 3xHPUS Mezereum 3xHPUS Petroleum 8xHPUS Pulsatilla 3xHPUS Thuja Occidentalis 10xHPUS The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United States."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:25.444362 · Updated: 2026-03-14T23:16:45.861926