RASH REPAIR BALM- zinc oxide ointment

Rash Repair Balm by

Drug Labeling and Warnings

Rash Repair Balm by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Product Integrity Laboratory, LLC, Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

ZINC OXIDE   20%

PURPOSE

SKIN PROTECTANT

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

• IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

INDICATIONS & USAGE

USES

• HELPS TREAT AND PREVENT RASHES AND SKIN CHAFING DUE TO
• EXPOSURE TO WETNESS AND FRICTION

WARNINGS

WARNINGS

• FOR EXTERNAL USE ONLY

WHEN USEING THIS PRODUCT

• AVOID CONTACT WITH EYES

STOP USE AND CONSULT A DOCTOR IF

• CONDITIONS WORSENS
• SYMPTOMS LAST MORE THAN 7 DAYS
• OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

DOSAGE & ADMINISTRATION

DIRECTIONS

• CLEANSE THE AFFECTED AREA AND ALLOW TO DRY
• APPLY BALM LIBERALLY, REPEAT UP TO THREE TO FOUR TIMES DAILY

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

• ALLATOIN, ALOE BARBADENSIS LEAF JUICE, BEESWAX, GLYCINE SOJA (SOYBEAN) OIL, HELIANTHUS ANNUUS (SUNFLOWER)
• SEED OIL, LIQUIDAMBAR ORIENTALIS (ORINTAL SWEET GUM), MYROXYLON BALSUMUM (BALSAM TOTU) RESIN, PARAFFIN,
• PETROLATUM, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SIMMONDSIA CHINENSIS (JOJOBA) OIL, STYRAX BENZOIN
• RESIN EXTRACT (BENZOIN), TOCOPHEROL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RASH REPAIR BALM 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.20 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
YELLOW WAX (UNII: 2ZA36H0S2V)
PARAFFIN (UNII: I9O0E3H2ZE)
ALLANTOIN (UNII: 344S277G0Z)
BENZOIN RESIN (UNII: GK21SBA74R)
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)
TOLU BALSAM (UNII: TD2LE91MBE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-110-01	60 g in 1 TUBE; Type 0: Not a Combination Product	09/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/20/2016

Labeler - Skinfix, Inc. (203158183)

Registrant - Product Integrity Laboratory, LLC (783863694)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(61328-110)