BUDPAK DIAPER RASH- zinc oxide cream

Budpak Diaper Rash by

Drug Labeling and Warnings

Budpak Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Budpak Inc. , Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 13%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out wetness

WARNINGS

Warnings

For external use only

WHEN USING

When using this product do not get into eyes

STOP USE

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again in few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

SPL UNCLASSIFIED SECTION

Other Information

Store at 20°to 25°C (68° to 77°F).

INACTIVE INGREDIENT

Inactive Ingredients

Water, Mineral Oil, Petrolatum, Beeswax, Dimethicone, Sorbitan Sesquioleate, Microcrystalline Wax, PEG-30 Dipolyhydroxystearate, Magnesium Sulfate, Phenoxyethanol, Methylparaben, Fragrance, Potassium Hydroxide, Propylparaben, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Diaper Rash Cream

Zinc Oxide 13%

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-028-14	1 in 1 BOX
1		14 g in 1 TUBE
2	NDC: 27293-028-28	1 in 1 BOX
2		28 g in 1 TUBE
3	NDC: 27293-028-35	1 in 1 BOX
3		35 g in 1 TUBE
4	NDC: 27293-028-42	1 in 1 BOX
4		42 g in 1 TUBE
5	NDC: 27293-028-02	1 in 1 BOX
5		113 g in 1 TUBE
6	NDC: 27293-028-03	1 in 1 BOX
6		226 g in 1 TUBE
7	NDC: 27293-028-04	453 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/14/2014

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-028)