drug facts

drug facts

SPL v1

SPL

SPL Set ID 0fa7105d-ee23-d73a-e063-6394a90a34f0

Route

topical

Published

Effective Date 2024-01-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

zinc oxide (40 mg) ascorbic acid (200 mg)

Inactive Ingredients

butylene glycol

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2024-01-24

Description

Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg

Medication Information

Warnings and Precautions

Stop using it immediately if there are signs of skin rashes or hypersensitivity.

Active Ingredient

Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg

Indications and Usage

Sprinkle on the affected area of the skin and rub it.

Once a day - below 100mg per day

Dosage and Administration

for topical use only

Description

Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

silicon dioxide

Section 51945-4

Section 55105-1

Antioxidation, Antiinflammatory on the skin

Structured Label Content

Warnings and Precautions (34071-1)

Stop using it immediately if there are signs of skin rashes or hypersensitivity.

Active Ingredient (55106-9)

Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg

Indications and Usage (34067-9)

Sprinkle on the affected area of the skin and rub it.

Once a day - below 100mg per day

Dosage and Administration (34068-7)

for topical use only

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

silicon dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antioxidation, Antiinflammatory on the skin

Advanced Ingredient Data

[{"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Sprinkle on the affected area of the skin and rub it. Once a day - below 100mg per day", "34068-7": "for topical use only", "34071-1": "Stop using it immediately if there are signs of skin rashes or hypersensitivity.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "silicon dioxide", "55105-1": "Antioxidation, Antiinflammatory on the skin", "55106-9": "Ascorbic acid 200mg, Zinc oxide 40mg per 1000mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:43.557159 · Updated: 2026-03-14T23:02:25.522673