EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL- menthol. zinc oxide cream

EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL by

Drug Labeling and Warnings

EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL by is a Otc medication manufactured, distributed, or labeled by DIVERSIFIED MANUFACTURING CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

MENTHOL 0.44%

ZINC OXIDE 20.6%

PURPOSE

EXTERNAL ANALGESIC/ANTI-ITCH

SKIN PROTECTANT/ ANANORECTAL ASTRINGENT

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

WARNINGS

FOR EXTERNAL USE ONLY.

NOT FOR USE ON DEEP OR PUNCTURE WOUNDS

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

STOP USE

STOP USE AND ASK A DOCTOR IF:

• CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

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

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

INACTIVE INGREDIENTS

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

QUESTIONS?

CALL 877.314.2554

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EMBRACE ANTI-ITCH SKIN PROTECTANT WITH CALAMINE AND MENTHOL 
menthol. zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62172-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHLOROTHYMOL (UNII: LJ25TI0CVT)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62172-311-16	180 g in 1 TUBE; Type 0: Not a Combination Product	05/04/2016
2	NDC: 62172-311-21	5 g in 1 POUCH; Type 0: Not a Combination Product	05/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/04/2016

Labeler - DIVERSIFIED MANUFACTURING CORP (185073996)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		185073996	manufacture(62172-311)