SPL v3
SPL
SPL Set ID f4f29808-059e-50b4-e053-2a95a90a3006
Route
ORAL
Published
Effective Date 2023-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisinin (0.6 g) Curcumin (2 g) Ascorbic Acid (6 g) Boswellia Sacra Bark (1.5 g)
Inactive Ingredients
.alpha.-tocopherol, Dl- Water Propanediol Castor Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-02-20

Description

Water-based suspension, dietary supplement Oral Spray


Medication Information

Warnings and Precautions

Keep out of reach of children. Not intended for pregnant or nursing woman. Discontinue use or consult your doctor if any adverse reactions occur. Do not use if inner bottle or spray cap is broken, or shows sign of tampering.

Indications and Usage

Adults apply 5 sprays, twice daily, into mouth.

Dosage and Administration

5 sprays provides 1 ml of ArtemiC. Servings per container: 4

Description

Water-based suspension, dietary supplement Oral Spray

Section 44425-7

Store in a dry, cool place and avoid heat and direct sunlight. Do not exceed temperatures above 77 deg F. Usable until expiration date. Once opened, use witjin 1 month. Do not freeze.

Section 50565-1

Keep Out of Reach of Children.

Section 51727-6

Water, Vegetable Castor Oil, Natural Propanediol, DL-Alpha-Tocopherol

Section 51945-4

NDC 83278-001-05

Bottle label NDC 83278-001-05

Section 55105-1

Dietary supplement to support the immune system.

Section 55106-9

Curcuma Longa Extract, Boswellia SerrataExtract, Antioxidant Artemisinin,Vitamin C (L-Ascorbic Acid)

Section 59845-8

Shake well before using. Adults apply 5 sprays, twice daily in the mouth, morning and evening for 2 consecutive days.preferably at least half hour before eating.


Structured Label Content

Indications and Usage (34067-9)

Adults apply 5 sprays, twice daily, into mouth.

Dosage and Administration (34068-7)

5 sprays provides 1 ml of ArtemiC. Servings per container: 4

Warnings and Precautions (34071-1)

Keep out of reach of children. Not intended for pregnant or nursing woman. Discontinue use or consult your doctor if any adverse reactions occur. Do not use if inner bottle or spray cap is broken, or shows sign of tampering.

Description (34089-3)

Water-based suspension, dietary supplement Oral Spray

Section 44425-7 (44425-7)

Store in a dry, cool place and avoid heat and direct sunlight. Do not exceed temperatures above 77 deg F. Usable until expiration date. Once opened, use witjin 1 month. Do not freeze.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51727-6 (51727-6)

Water, Vegetable Castor Oil, Natural Propanediol, DL-Alpha-Tocopherol

Section 51945-4 (51945-4)

NDC 83278-001-05

Bottle label NDC 83278-001-05

Section 55105-1 (55105-1)

Dietary supplement to support the immune system.

Section 55106-9 (55106-9)

Curcuma Longa Extract, Boswellia SerrataExtract, Antioxidant Artemisinin,Vitamin C (L-Ascorbic Acid)

Section 59845-8 (59845-8)

Shake well before using. Adults apply 5 sprays, twice daily in the mouth, morning and evening for 2 consecutive days.preferably at least half hour before eating.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)