SPL v1
SPL
SPL Set ID 49496525-1d1d-637f-e063-6294a90ab89b
Route
TOPICAL
Published
Effective Date 2026-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g) Undecylenic Acid (10 g)
Inactive Ingredients
Tea Tree Oil Glycerin Witch Hazel Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-26
Description

Undecylenic Acid (10%), Zinc Oxide (15%)

Medication Information

Warnings and Precautions

Warnings:For external use only. Avoid contact with eyes. Discontinue use ifirritation occurs. Keep out of reach of children.

Indications and Usage

A brief cooling or tingling sensation may be felt when first applied.. This is normal and typically fades within a few minutes. The cooling effect is part of how the formula works on irritated skin

Dosage and Administration

Use 2-3 times daily

Description

Undecylenic Acid (10%), Zinc Oxide (15%)

Section 50565-1

Keep out of reach of children

Section 51727-6

Witch Hazel Extract, Tea Tree Oil,Glycerin, Purified Water.

Section 51945-4

Section 55105-1

Helps soothe skin fold rash (intertrigo) and irritation caused by moisture and friction in areas such as under the breasts, abdominal folds, inner thighs, andgroin.

Section 55106-9

Undecylenic Acid (10%), Zinc Oxide (15%)

Structured Label Content

Indications and Usage (34067-9)

A brief cooling or tingling sensation may be felt when first applied.. This is normal and typically fades within a few minutes. The cooling effect is part of how the formula works on irritated skin

Dosage and Administration (34068-7)

Use 2-3 times daily

Warnings and Precautions (34071-1)

Warnings:For external use only. Avoid contact with eyes. Discontinue use ifirritation occurs. Keep out of reach of children.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Witch Hazel Extract, Tea Tree Oil,Glycerin, Purified Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps soothe skin fold rash (intertrigo) and irritation caused by moisture and friction in areas such as under the breasts, abdominal folds, inner thighs, andgroin.

Section 55106-9 (55106-9)

Undecylenic Acid (10%), Zinc Oxide (15%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.172292 · Updated: 2026-03-14T23:12:35.594126