- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- helps treat and prevent diaper rash.
- protects chafed skin due to diaper rash and helps protect skin from wetness.
- helps treat and prevent diaper rash.
- Warnings
For external use only.
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.
- condition worsens
- 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.
- Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
- 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.
- Store at 68-77° F (20-25° C) [see USP Controlled Room Temperature]
- 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).\
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- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Z-BUM
diaper rash cream creamProduct 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)