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SPL v1

SPL

SPL Set ID 22db95d8-1230-9cdf-e063-6394a90a7582

Route

TOPICAL

Published

Effective Date 2024-09-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Centella Asiatica Triterpenoids (6 mg) Niacinamide (4.5 mg) Ascorbic Acid (3 mg) Glutathione (9 mg) Chamomile

Inactive Ingredients

Allantoin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-24

Description

GLUTATHIONE, CENTELLA ASIATICA EXTRACT,ASCORBIC ACID,NIACINAMIDE, CHAMOMILLA RECUTITA(MATRICARIA) FLOWER EXTRACT

Purpose

Elastic and smooth skin

Medication Information

Purpose

Elastic and smooth skin

Description

GLUTATHIONE, CENTELLA ASIATICA EXTRACT,ASCORBIC ACID,NIACINAMIDE, CHAMOMILLA RECUTITA(MATRICARIA) FLOWER EXTRACT

Use

1. Clean and dry skin

2. Apply to skin until completely absorbed

3. For best results, use twice aday in the morning and evening

Section 44425-7

Avoid freezing and excessive heat above 40C (104F) ）

Store in a cool and dry place.

Section 50565-1

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

Section 51727-6

ALLANTOIN

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 Ingredient(s)

GLUTATHIONE, CENTELLA ASIATICA EXTRACT,ASCORBIC ACID,NIACINAMIDE, CHAMOMILLA RECUTITA(MATRICARIA) FLOWER EXTRACT

Structured Label Content

Use

1. Clean and dry skin

2. Apply to skin until completely absorbed

3. For best results, use twice aday in the morning and evening

Section 44425-7 (44425-7)

Avoid freezing and excessive heat above 40C (104F) ）

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)

ALLANTOIN

Section 51945-4 (51945-4)

Purpose

Elastic and smooth skin

Stop Use (STOP USE)

Discontinue use if signs of irritation or rash occur

Warnings

Do Not Use (Do not use)

Discontinue use if signs of irritation or rash occur

Active Ingredient(s)

GLUTATHIONE, CENTELLA ASIATICA EXTRACT,ASCORBIC ACID,NIACINAMIDE, CHAMOMILLA RECUTITA(MATRICARIA) FLOWER EXTRACT

Advanced Ingredient Data

[{"name": "CENTELLA ASIATICA TRITERPENOIDS", "unii": "4YS74Q4G4J", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "GLUTATHIONE", "unii": "GAN16C9B8O", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "9", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}]

Raw Label Data

All Sections (JSON)

{"Use": "1. Clean and dry skin 2. Apply to skin until completely absorbed 3. For best results, use twice aday in the morning and evening", "44425-7": "Avoid freezing and excessive heat above 40C (104F) ） Store in a cool and dry place.", "50565-1": "Please keep out of reach of children. Do not swallow.", "51727-6": "ALLANTOIN", "Purpose": "Elastic and smooth skin", "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 Ingredient(s)": "GLUTATHIONE, CENTELLA ASIATICA EXTRACT,ASCORBIC ACID,NIACINAMIDE, CHAMOMILLA RECUTITA(MATRICARIA) FLOWER EXTRACT"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:37.448139 · Updated: 2026-03-14T23:03:48.236290