FDA.reportPublic FDA data

EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL

Manufacturer
DIVERSIFIED MANUFACTURING CORP
Effective date
2022-01-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:13:06

Label at a glance#

ProductEMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL
Active ingredientMENTHOL, ZINC OXIDE
Label structure11 sections

Indications and uses

A MOISTURE BARRIER THAT PREVENTS & HELPS HEAL SKIN IRRIATATIONS FROM URINE DIARHEA PERSPIRATION FISTULA DRAINAGE FEEDING TUBE SITE LEAKAGE WOUND DRAINAGE (PERI WOUND SKIN) MINOR BURNS CUTS SCRAPES ITCHING

Dosage and administration

CLEAN SKIN GENTLY WITH MILD SKIN CLEANSER. PAT DRY OR ALLOW TO AIR DRY. APPLY A THIN LAYER TO REDDENED OR IRRITATED SKIN 2-4 TIMES DAILY, OR AFTER EACH INCONTINENT EPISODE TO PROMOTE COMFORT AND LONG LASTING PROTECTION.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 0.44%

ZINC OXIDE 20.6%

PURPOSE

OTC - PURPOSE SECTION

EXTERNAL ANALGESIC/ANTI-ITCH

SKIN PROTECTANT/ ANANORECTAL ASTRINGENT

USES

INDICATIONS & USAGE SECTION

A MOISTURE BARRIER THAT PREVENTS & HELPS HEAL SKIN IRRIATATIONS FROM

  • URINE
  • DIARHEA
  • PERSPIRATION
  • FISTULA DRAINAGE
  • FEEDING TUBE SITE LEAKAGE
  • WOUND DRAINAGE (PERI WOUND SKIN)
  • MINOR BURNS
  • CUTS
  • SCRAPES
  • ITCHING

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

NOT FOR USE ON DEEP OR PUNCTURE WOUNDS

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, FLUSH THOROUGHLY WITH WATER.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF:

  • CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION CONTACT A PHYSICIAN OR POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

CLEAN SKIN GENTLY WITH MILD SKIN CLEANSER. PAT DRY OR ALLOW TO AIR DRY. APPLY A THIN LAYER TO REDDENED OR IRRITATED SKIN 2-4 TIMES DAILY, OR AFTER EACH INCONTINENT EPISODE TO PROMOTE COMFORT AND LONG LASTING PROTECTION.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • STORE AT ROOM TEMPERATURE 59° - 86°F (15° - 30°C).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CALAMINE, CHLOROTHYMOL, GLYCERIN, LANOLIN, PHENOL, SODIUM BICARBONATE, THYMOL

QUESTIONS?

OTC - QUESTIONS SECTION

CALL 877.314.2554

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Embrace_Anti-Itch Cream_6oz.jpgEmbrace_Anti-Itch Cream_6oz.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62172-31162172-311-16, 62172-311-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
CHLOROTHYMOLLJ25TI0CVTIACT
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
PHENOL339NCG44TVIACT
SODIUM BICARBONATE8MDF5V39QOIACT
THYMOL3J50XA376EIACT
MENTHOLL7T10EIP3AACTIB
ZINC OXIDESOI2LOH54ZACTIM

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
101c9203-c1e7-ad09-e063-6294a90a3f770fa80b37-cd89-4c8a-a9c3-5ed2bab5bd6b2024-01-29WarningsExact identifier
spl set id: 0fa80b37-cd89-4c8a-a9c3-5ed2bab5bd6b

Reported adverse events (FAERS/openFDA)#

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