DR. MOM BUTT BALM- dimethicone petrolatum ointment
Ferndale Laboratories, Inc.

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.

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Dr. Mom Butt Balm

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

Dr. Mom Butt Balm Carton

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)