84844-005

84844-005
SPL v1
SPL
SPL Set ID 25bd4fc8-af2d-a36d-e063-6394a90a4278
Route
topical
Published
Effective Date 2024-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
niacinamide (15 g)
Inactive Ingredients
allantoin centella asiatica water chamomile ascorbic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-10-31

Purpose

Anti-hyperpigmentation

Description

NIACINAMIDE 15%


Medication Information

Warnings

For external use only.

Purpose

Anti-hyperpigmentation

Directions

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

EDITStore between 15-30C (59-86F) Avoid freezingand excessive heat above 40C (104F)

Inactive Ingredients

ASCORBIC ACID,WATER,CHAMOMILE,CENTELLA ASIATICA,ALLANTOIN

Description

NIACINAMIDE 15%

Principal Display Panel

Use

Used to whiten or lighten skin pigmentation.

Stop Use

Discontinue use if signs of irritation or rash occur.

Ask Doctor

Discontinue use if signs of irritation or rash occur.

Do Not Use

if irritation or allergic reactions develop.

on damaged or broken skin. on individuals aged 12 and under.

When Using

section When using this productavoid contact with eyes.

Please test this cream on a small patch of your the inside of the arm if it is your first time using this cream.

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

Active Ingredient

NIACINAMIDE 15%

Keep Oot of Reach of Children

Please keep out of reach of children.


Structured Label Content

Warnings

For external use only.

Purpose

Anti-hyperpigmentation

Directions

Place enough product on hands to cover all surfaces.

Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

EDITStore between 15-30C (59-86F) Avoid freezingand excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

ASCORBIC ACID,WATER,CHAMOMILE,CENTELLA ASIATICA,ALLANTOIN

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Used to whiten or lighten skin pigmentation.

Stop Use

Discontinue use if signs of irritation or rash occur.

Ask Doctor

Discontinue use if signs of irritation or rash occur.

Do Not Use (Do not use)

if irritation or allergic reactions develop.

on damaged or broken skin. on individuals aged 12 and under.

When Using

section When using this productavoid contact with eyes.

Please test this cream on a small patch of your the inside of the arm if it is your first time using this cream.

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

Active Ingredient

NIACINAMIDE 15%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Please keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)