49496525-1d1d-637f-e063-6294a90ab89b

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.

Active Ingredient

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

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.

Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

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

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

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.

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