Search by Drug Name or NDC

NDC 45737-0701-04 BioDCream 15.25 g/100g Details

BioDCream 15.25 g/100g

BioDCream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is ZINC OXIDE.

Product Information

NDC	45737-0701
Product ID	45737-701_56418335-c450-468d-8ff1-37747778a7f6
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BioDCream
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	15.25
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Advanced Generic Corporation
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 45737-0701-04 (45737070104)

Pricing Information	N/A
NDC Package Code	45737-701-04
Billing NDC	45737070104
Package	125 g in 1 JAR (45737-701-04)
Marketing Start Date	2016-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 89a3a755-0928-471b-95ed-8b07d08e4675 Details

Active Ingredient

Zinc Oxide 15.25%

Purpose

Skin protectant

Uses

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

Warnings

For external use only.

When using this product avoid contact with eyes.
Stop use and ask doctor if condition worsens or lasts more than 7 days

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

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

Inactive ingredients

beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil, lavender fragrance, methylparaben, paraffinum liquidum, propylene glycol, propylparaben, white petrolatum.

Questions or comments:

1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIODCREAM

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45737-701
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LANOLIN OIL (UNII: OVV5IIJ58F)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45737-701-04	125 g in 1 JAR; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	04/01/2016

Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020

Document Id: 56418335-c450-468d-8ff1-37747778a7f6

Set id: 89a3a755-0928-471b-95ed-8b07d08e4675

Version: 4

Effective Time: 20201223