Z-BUM- diaper rash cream cream

Z-Bum by

Drug Labeling and Warnings

Z-Bum by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Z-Bum

NDC: 58809-375-04

4 oz. (113 grams)

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 68-77° F (20-25° C) [see USP Controlled Room Temperature]
  
• Lot No and Exp Date: see box or see crimp of tube.

Inactive ingredients

Purified Water, White Petrolatum, Glycerine, Light Mineral Oil, Cetyl Alcohol, Stearyl Alcohol, Ceteareth- 20, Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Chlorphenesin, Phenoxyethanol, and Tocopheryl Acetate (Vitamin E).\

Questions or comments?

1-888-535-0305

Manufactured for:
GM Pharmaceuticals, Inc.

Arlington, TX 76015

P1117.00

R071216

PRINCIPAL DISPLAY PANEL

NDC58809-375-04
Z-BUM
Daily Moisturizing Diaper Rash Cream
NET WT 4 oz (113 grams)

INGREDIENTS AND APPEARANCE

Z-BUM 
diaper rash cream cream

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

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

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM P-CHLORO-M-CRESOL (UNII: 343KVA8Y38)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2015

Labeler - GM Pharmaceuticals, INC (793000860)