FDA.reportPublic FDA data

Active Ingredients

Manufacturer
Twin Med LLC
Effective date
2026-09-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-02 01:03:37

Label at a glance#

ProductProCure SkinGuard
Active ingredientZINC OXIDE, PETROLATUM
Label structure7 sections

Indications and uses

Helps treat and prevent incontinence or diaper rash Protects chafed skin associated with incontinence or diaper rash and helps seal out wetness Temporarily protects and helps relieve chafed, chapped or cracked skin

Dosage and administration

As a Skin Protectant: Apply as needed For Incontinence or Diaper Rash: Change wet and soild undergarments promptly Gently cleanse affected skin, and allow to dry Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 49.9%

Zinc Oxide 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent incontinence or diaper rash
  • Protects chafed skin associated with incontinence or diaper rash and helps seal out wetness
  • Temporarily protects and helps relieve chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into the eyes

Stop use and as a doctor if

OTC - STOP USE SECTION

  • Condition worsenes
  • symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion contact a physician or Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

As a Skin Protectant: Apply as needed

For Incontinence or Diaper Rash:

  • Change wet and soild undergarments promptly
  • Gently cleanse affected skin, and allow to dry
  • Apply ointment liberally as often as necessary, with each undergarment change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Juice, Chloroxylenol, Corn Oil, Lanolin, Methylparaben, Mineral OIl, Paraffin, Phenoxyethanol, Propylene Glycol, Propylparaben, Sorbitan, Sesquioleate, Vitamin A Palmitate, Vitamin D (Cholecalciferol), Vitamin E (Alpha-Tocopheryl Acetate), Water, White Wax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCPG35 PCPG35 ImagePCPG35 Image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10840330701164GTIN-14: 10840330701164
GTIN storage (14 digits): 10840330701164		PCPG35 Image 9.2026.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-07755681-077-35, 55681-077-05, 55681-077-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
CHOLECALCIFEROL1C6V77QF41IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
WHITE WAX7G1J5DA97FIACT
LANOLIN7EV65EAW6HIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PARAFFINI9O0E3H2ZEIACT
CORN OIL8470G57WFMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CHLOROXYLENOL0F32U78V2QIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 98 · 1,954 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsName fallback
generic name: ZINC OXIDE
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsName fallback
generic name: ZINC OXIDE
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsName fallback
generic name: ZINC OXIDE
Hero Force Shield Superlight Sunscreen SPF 30ZINC OXIDEChurch & Dwight Co., Inc.140268a9-adb9-4574-ad82-4a2e924dc8082026-08-26WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsName fallback
generic name: ZINC OXIDE
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsName fallback
generic name: ZINC OXIDE
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsName fallback
generic name: ZINC OXIDE
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsName fallback
generic name: ZINC OXIDE
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsName fallback
generic name: ZINC OXIDE
Zinc OxideZINC OXIDEADUSA Distribution, LLC5940399c-31e3-6d51-e063-6294a90a8e7c2026-08-17Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Sun Zapper - Acne Pure Zinc Sunscreen SPF50ZINC OXIDEVeganic SKN Limited3ee435a5-70fb-0c8a-e063-6394a90a650a2026-08-16WarningsName fallback
generic name: ZINC OXIDE
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsName fallback
generic name: ZINC OXIDE
TENA Proskin protective creamZINC OXIDEEssity HMS North America Inc.b840377f-a297-4aff-900e-7ea8b7c987172026-08-13Warnings, Adverse reactionsName fallback
generic name: ZINC OXIDE
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsName fallback
generic name: ZINC OXIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.