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Budpak Diaper Rash

Dosage form: cream
Ingredients: ZINC OXIDE 13g in 100g
Labeler: Budpak Inc.
NDC Code: 27293-028

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Budpak Diaper Rash Cream

Active Ingredient

Zinc Oxide 13%

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash. Helps seal out 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 in few days.

Keep out of reach of children.

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

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.

Other Information

Store at 20°to 25°C (68° to 77°F).

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.

PRINCIPAL DISPLAY PANEL

Budpak Diaper Rash Cream

Zinc Oxide 13%

NET WT 1 OZ (28 g)

BUDPAK DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-028
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PETROLATUM 
YELLOW WAX 
DIMETHICONE 
SORBITAN SESQUIOLEATE 
MICROCRYSTALLINE WAX 
PEG-30 DIPOLYHYDROXYSTEARATE 
MAGNESIUM SULFATE 
PHENOXYETHANOL 
METHYLPARABEN 
POTASSIUM HYDROXIDE 
PROPYLPARABEN 
.ALPHA.-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
1NDC:27293-028-141 TUBE in 1 BOX
114 g in 1 TUBE
2NDC:27293-028-281 TUBE in 1 BOX
228 g in 1 TUBE
3NDC:27293-028-351 TUBE in 1 BOX
335 g in 1 TUBE
4NDC:27293-028-421 TUBE in 1 BOX
442 g in 1 TUBE
5NDC:27293-028-021 TUBE in 1 BOX
5113 g in 1 TUBE
6NDC:27293-028-031 TUBE in 1 BOX
6226 g in 1 TUBE
7NDC:27293-028-04453 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/14/2014
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-028)

Revised: 02/2014
 
Budpak Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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