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NDC 00496-0590-02 Dr. Mom Butt Balm .28; .48 g/g; g/g Details

Dr. Mom Butt Balm .28; .48 g/g; g/g

Dr. Mom Butt Balm is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is DIMETHICONE; WHITE PETROLATUM.

Product Information

NDC	00496-0590
Product ID	0496-0590_ec06f1fd-c3e2-5dfc-e053-2a95a90a7cdd
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	Dr. Mom Butt Balm
Proprietary Name Suffix	n/a
Non-Proprietary Name	dimethicone petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.28; .48
Active Ingredient Units	g/g; g/g
Substance Name	DIMETHICONE; WHITE PETROLATUM
Labeler Name	Ferndale Laboratories, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M016
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00496-0590-02 (00496059002)

Pricing Information	N/A
NDC Package Code	0496-0590-02
Billing NDC	00496059002
Package	70 g in 1 TUBE (0496-0590-02)
Marketing Start Date	2022-11-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd Details

Active Ingredients

Dimethicone 28%

Petrolatum 48%

Purpose

Dimethicone 28%..........Skin protectant

Petrolatum 48%............Skin protectant

Uses

helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin

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

Do not use on

deep or puncture wounds
animal bites
serious burns

Keep out of reach of children.

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

Directions

apply as needed

Other information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

aluminum starch octenylsuccinate, fractionated coconut oil, magnesium hydroxide, spearmint oil

Questions?

Toll free (888) 548-0900

Package Display

INGREDIENTS AND APPEARANCE

DR. MOM BUTT BALM

dimethicone petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0590
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.28 g in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	0.48 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SPEARMINT OIL (UNII: C3M81465G5)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0496-0590-02	70 g in 1 TUBE; Type 0: Not a Combination Product	11/07/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	11/07/2022

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0590)

Revised: 10/2022

Document Id: ec06f1fd-c3e2-5dfc-e053-2a95a90a7cdd

Set id: ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd

Version: 1

Effective Time: 20221027