83818-001 update

SPL v2

SPL

SPL Set ID 0a8c7bdb-19f4-54c9-e063-6394a90ac5f5

Route

topical

Published

Effective Date 2023-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (0.15 g) didecyldimonium (0.025 g) niacinamide (0.5 g)

Inactive Ingredients

dimethicone cyclomethicone 5 propylene glycol cyclomethicone 6 allantoin hydroxyacetophenone

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-11-19

Purpose

Fat grandule clearing Skin essence

Description

Didecyl Dimethyl Ammonium Chloride 0.025% Salicylic Acid 0.15% NIACINAMIDE 0.5%

Medication Information

Warnings

For external use only

Keep away from fire and flame

Purpose

Fat grandule clearing Skin essence

Directions

Slide the essence on the promatic area and use fingertips to massage until fully absorbed.

Other Information

Before use, read all information on the carton

Inactive Ingredients

DIMETHICONE,CYCLOPENTASILOXANE,PROPYLENE GLYCOL,HYDROXYACETOPHENONE,CYCLOHEXASILOXANE,ALLANTOIN

Description

Didecyl Dimethyl Ammonium Chloride 0.025% Salicylic Acid 0.15% NIACINAMIDE 0.5%

Principal Display Panel

Use

to fight and reduce signs of milia

Stop Use

if rash or irritation happens

Questions

[email protected]

Ask Doctor

When Pregnant or breast-feeding

Do Not Use

if rash or irritation happens

When Using

Do not apply on other parts of the body

Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

Active Ingredient

Didecyl Dimethyl Ammonium Chloride 0.025%

Salicylic Acid 0.15%

NIACINAMIDE 0.5%

Keep Oot of Reach of Children

Keep Oot Of Reach Of Children

Structured Label Content

Warnings

For external use only

Keep away from fire and flame

Purpose

Fat grandule clearing Skin essence

Directions

Slide the essence on the promatic area and use fingertips to massage until fully absorbed.

Other Information (Other information)

Before use, read all information on the carton

Inactive Ingredients (Inactive ingredients)

DIMETHICONE,CYCLOPENTASILOXANE,PROPYLENE GLYCOL,HYDROXYACETOPHENONE,CYCLOHEXASILOXANE,ALLANTOIN

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

to fight and reduce signs of milia

Stop Use

if rash or irritation happens

Questions

[email protected]

Ask Doctor

When Pregnant or breast-feeding

Do Not Use (Do not use)

if rash or irritation happens

When Using

Do not apply on other parts of the body

Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

Active Ingredient

Didecyl Dimethyl Ammonium Chloride 0.025%

Salicylic Acid 0.15%

NIACINAMIDE 0.5%

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

Keep Oot Of Reach Of Children

Advanced Ingredient Data

[{"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIDECYLDIMONIUM", "unii": "Z7F472XQPA", "classCode": "ACTIB", "strengthNumerator": "0.025", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NIACINAMIDE", "unii": "25X51I8RD4", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 6", "unii": "XHK3U310BA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "to fight and reduce signs of milia", "Purpose": "Fat grandule clearing Skin essence", "Stop Use": "if rash or irritation happens", "Warnings": "For external use only Keep away from fire and flame", "Questions": "novensabeauty@gmail.com", "Ask Doctor": "When Pregnant or breast-feeding", "Directions": "Slide the essence on the promatic area and use fingertips to massage until fully absorbed.", "Do not use": "if rash or irritation happens", "When Using": "Do not apply on other parts of the body Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water", "Active Ingredient": "Didecyl Dimethyl Ammonium Chloride 0.025% Salicylic Acid 0.15% NIACINAMIDE 0.5%", "Other information": "Before use, read all information on the carton", "Inactive ingredients": "DIMETHICONE,CYCLOPENTASILOXANE,PROPYLENE GLYCOL,HYDROXYACETOPHENONE,CYCLOHEXASILOXANE,ALLANTOIN", "Keep Oot Of Reach Of Children": "Keep Oot Of Reach Of Children"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:12.005436 · Updated: 2026-03-14T23:06:40.095610