DR. MOM BUTT BALM- dimethicone petrolatum ointment

Dr. Mom Butt Balm by

Drug Labeling and Warnings

Dr. Mom Butt Balm by is a Otc medication manufactured, distributed, or labeled by Ferndale Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dimethicone 28%

White Petrolatum 48%

Purpose

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

White 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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

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

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

Labeler - Ferndale Laboratories, Inc. (005320536)

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