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SPL v13

SPL

SPL Set ID 27fbdc34-bc3d-9d63-e063-6394a90a79ab

Route

TOPICAL

Published

Effective Date 2025-01-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Stearic Acid (40 mg) Glycerin (190 mg) Sorbitol (300 mg)

Inactive Ingredients

Water

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-08

Description

niacinamide-----1% ，Sorbitol---6%，stearic acid---17%

Purpose

relieve pain

Medication Information

Purpose

relieve pain

Description

niacinamide-----1% ，Sorbitol---6%，stearic acid---17%

Stop

rash occurs

Usage

Limited to use on the surface of the skin only

Section 43683-2

stop using

Storage

Windproof and Waterproof

Warnings

For external use only

Do Not Use

on damaged or broken skin

When Using

keep out of eyes. Rinse with water to remove.

Active Ingredient

niacinamide-----1% ，Sorbitol---6%，stearic acid---17%

Inactive Ingredient

water-------30%

Principal Display Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

For External Use Only On the Skin

For external use only on the skin

Use According to the Instructions Or Doctor's Advice

Use according to the instructions or doctor's advice

Structured Label Content

Stop (stop)

rash occurs

Usage (usage)

Limited to use on the surface of the skin only

Section 43683-2 (43683-2)

stop using

Purpose

relieve pain

Storage (storage)

Windproof and Waterproof

Warnings (warnings)

For external use only

Do Not Use (do not use)

on damaged or broken skin

When Using (when using)

keep out of eyes. Rinse with water to remove.

Active Ingredient (active ingredient)

niacinamide-----1% ，Sorbitol---6%，stearic acid---17%

Inactive Ingredient (INACTIVE INGREDIENT)

water-------30%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

For External Use Only On the Skin (For external use only on the skin)

For external use only on the skin

Use According to the Instructions Or Doctor's Advice (Use according to the instructions or doctor's advice)

Use according to the instructions or doctor's advice

Advanced Ingredient Data

[{"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "190", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "300", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"stop": "rash occurs", "usage": "Limited to use on the surface of the skin only", "43683-2": "stop using", "Purpose": "relieve pain", "storage": "Windproof and Waterproof", "warnings": "For external use only", "do not use": "on damaged or broken skin", "when using": "keep out of eyes. Rinse with water to remove.", "active ingredient": "niacinamide-----1% ，Sorbitol---6%，stearic acid---17%", "INACTIVE INGREDIENT": "water-------30%", "keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "For external use only on the skin": "For external use only on the skin", "Use according to the instructions or doctor's advice": "Use according to the instructions or doctor's advice"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.408088 · Updated: 2026-03-14T23:06:47.753582