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NDC 73570-0001-02 Doctor Os Diaper Balm 30 g/100g Details

Doctor Os Diaper Balm 30 g/100g

Doctor Os Diaper Balm is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. O's Dermabalm, Llc. The primary component is ZINC OXIDE.

Product Information

NDC	73570-0001
Product ID	73570-001_ad68adab-ec03-4d5d-b38e-322d1cc578cb
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	Doctor Os Diaper Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	30
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	Dr. O's Dermabalm, Llc
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 73570-0001-02 (73570000102)

Pricing Information	N/A
NDC Package Code	73570-001-02
Billing NDC	73570000102
Package	1 TUBE in 1 CARTON (73570-001-02) / 100 g in 1 TUBE
Marketing Start Date	2020-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL df3769af-cf00-4340-9ac9-4697edfd1319 Details

Drug Facts

Active ingredients

Zinc Oxide 30%

Purpose

Skin protectant

Uses

Helps treat and prevent diaper rash
Protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

For external use only.

When using this product • Keep out of 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 the reach of children. If swallowed seek medical attention or contact a Poison Control Center right away.

Directions

change wet and 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 anytime when exposure to wet diapers may be prolonged

Other information

Store between 15 and 30°C (59 and 86°F).

Inactive ingredients

Lanolin, corn starch, soy lecithin, sesame seed oil, fragrance

Packaging

INGREDIENTS AND APPEARANCE

DOCTOR OS DIAPER BALM

zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73570-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SESAME OIL (UNII: QX10HYY4QV)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73570-001-02	1 in 1 CARTON	02/14/2020
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/14/2020

Labeler - Dr. O's Dermabalm, Llc (016334106)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL TECHNOLOGY, LLC		618561906	manufacture(73570-001)

Revised: 7/2021

Document Id: ad68adab-ec03-4d5d-b38e-322d1cc578cb

Set id: df3769af-cf00-4340-9ac9-4697edfd1319

Version: 2

Effective Time: 20210708