BUYBUYBABY QUICK RELIEF DIAPER RASH CREAM- zinc oxide cream

buybuyBABY by

Drug Labeling and Warnings

buybuyBABY by is a Otc medication manufactured, distributed, or labeled by Harmon Stores Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide, 13.0%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps seal out wetness

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away

DOSAGE & ADMINISTRATION

Directions

-change wet and soiled diapers promptly  -cleanse the diaper area

-allow to dry  -apply cream liberally as often as necessary, with each diaper

change, especially at bedtime or at any time when exposure to wet diapers may

be prolonged

STORAGE AND HANDLING

Other information

-store at 20 to 25 C    (68 to 77 F)

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, beeswax, dimethicone,

magnesium sulfate, methylparaben, microcrystalline wax,

mineral oil, PEG-30 dipolyhydroxystearate, petrolatum,

phenoxyethanol, polyglyceryl-3 diostearate,

potassium hydroxide, proprylparaben, sorbitan,

sesquioleate, tocopheryl acetate (vitamin E), water

DESCRIPTION

Maximum Strength Diaper Rash Paste provides maximum strength relief

overnight for baby's delicate skin. This rich and dermatologist-tested

formula instantly forms a protection layer

on your baby's skin to soothe and relieve discomfort caused

by diaper rash.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUYBUYBABY  QUICK RELIEF DIAPER RASH CREAM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.69 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
METHYLPARABEN (UNII: A2I8C7HI9T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-113-17	1 in 1 CARTON	12/07/2016
1	NDC: 63940-113-16	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/07/2016

Labeler - Harmon Stores Inc. (804085293)