Active ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash

■ protects chafed skin due to diaper rash and helps protect skin from wetness

Warnings

For external use only

When using this product

do not get into eyes.

Stop use and ask a doctor if

■ condition worsens

■ symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.

■ apply cream liberally as often as necessary, with each diaper change, especially at

bedtime or anytime when exposure to wet diapers may be prolonged.

Other information

■ store at 20-30°C (68-86°F)

Inactive ingredients

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, petrolatum, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E)

Questions or comments?

Call 1-888-535-0305

Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118

PRINCIPAL DISPLAY PANEL

NDC 58809-375-04

Z-BUM

Zinc Oxide 22% (Skin Protectant)

Diaper Rash Cream

Premium Protection

Helps heal, soothe, and prevent diaper rash

Protects chafed skin

SOOTHING ALOE & VITAMIN E

Gentle on sensitive skin

NET WT 4 oz (113 grams)

Z-Bum 2024

Z-BUM
diaper rash cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58809-375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58809-375-04	113 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	12/01/2015

Labeler - GM Pharmaceuticals, INC (793000860)