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SPL v1

SPL

SPL Set ID 7ce094b3-116a-dc61-e053-2a91aa0a9dfe

Route

ORAL

Published

Effective Date 2018-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ascorbic Acid (156 mg) .alpha.-tocopherol (10 mg) Carbazochrome (2 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Sodium Starch Glycolate Type A Corn Microcrystalline Cellulose Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: IgatanF Shape: capsule Color: yellow Size: 18 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-11-20

Description

COATED ASCORBIC ACID, TOCOPHEROL ACETATE, CARBAZOCHROME, LYSOZYME CHLORIDE

Medication Information

Warnings and Precautions

Please refer to the leaflet enclosed.

Indications and Usage

Adults: Take one capsule three times a day after meals.

Dosage and Administration

For oral use only

Description

COATED ASCORBIC ACID, TOCOPHEROL ACETATE, CARBAZOCHROME, LYSOZYME CHLORIDE

Section 50565-1

Keep out of reach of children

Section 51727-6

Corn starch, Lactose hydrate, Microcrystalline cellulose, Sodium starch glycolate, Colloidal silicon dioxide, Magnesium stearate, Capsule, Sunset yellow FCF, Quinoline yellow WS

Section 51945-4

Section 55105-1

Preventing further damage to the gum tissue

Anti-inflammatory and Hemostatic action

Synergistic effect of periodontal disease treatment

Section 55106-9

COATED ASCORBIC ACID, TOCOPHEROL ACETATE, CARBAZOCHROME, LYSOZYME CHLORIDE

Structured Label Content

Indications and Usage (34067-9)

Adults: Take one capsule three times a day after meals.

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Please refer to the leaflet enclosed.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Corn starch, Lactose hydrate, Microcrystalline cellulose, Sodium starch glycolate, Colloidal silicon dioxide, Magnesium stearate, Capsule, Sunset yellow FCF, Quinoline yellow WS

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Preventing further damage to the gum tissue

Anti-inflammatory and Hemostatic action

Synergistic effect of periodontal disease treatment

Section 55106-9 (55106-9)

COATED ASCORBIC ACID, TOCOPHEROL ACETATE, CARBAZOCHROME, LYSOZYME CHLORIDE

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "156", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARBAZOCHROME", "unii": "81F061RQS4", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Adults: Take one capsule three times a day after meals.", "34068-7": "For oral use only", "34071-1": "Please refer to the leaflet enclosed.", "50565-1": "Keep out of reach of children", "51727-6": "Corn starch, Lactose hydrate, Microcrystalline cellulose, Sodium starch glycolate, Colloidal silicon dioxide, Magnesium stearate, Capsule, Sunset yellow FCF, Quinoline yellow WS", "55105-1": "Preventing further damage to the gum tissue Anti-inflammatory and Hemostatic action Synergistic effect of periodontal disease treatment", "55106-9": "COATED ASCORBIC ACID, TOCOPHEROL ACETATE, CARBAZOCHROME, LYSOZYME CHLORIDE"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.656809 · Updated: 2026-03-14T22:55:20.733713