Dr. Mom Butt Balm

SPL v2

SPL

SPL Set ID ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd

Route

TOPICAL

Published

Effective Date 2022-10-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (0.28 g) White Petrolatum (0.48 g)

Inactive Ingredients

Aluminum Starch Octenylsuccinate Medium-chain Triglycerides Spearmint Oil Magnesium Hydroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-07

Description

Dimethicone 28% White Petrolatum 48%

Purpose

Dimethicone 28%..........Skin protectant White Petrolatum 48%............Skin protectant

Medication Information

Purpose

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

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

Description

Dimethicone 28% White Petrolatum 48%

Uses

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

Warnings

For external use only.

Directions

apply as needed

Questions?

Toll free (888) 548-0900

Do Not Use On

deep or puncture wounds
animal bites
serious burns

Package Display

Other Information

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

Active Ingredients

Dimethicone 28%

White Petrolatum 48%

Inactive Ingredients

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

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

Keep Out of Reach of Children.

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

Structured Label Content

Uses

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

Purpose

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

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

Warnings

For external use only.

Directions

apply as needed

Questions?

Toll free (888) 548-0900

Do Not Use On (Do not use on)

deep or puncture wounds
animal bites
serious burns

Package Display

Other Information (Other information)

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

Active Ingredients

Dimethicone 28%

White Petrolatum 48%

Inactive Ingredients

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

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (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 Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "0.28", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALUMINUM STARCH OCTENYLSUCCINATE", "unii": "I9PJ0O6294", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SPEARMINT OIL", "unii": "C3M81465G5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "ACTIB", "strengthNumerator": "0.48", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MAGNESIUM HYDROXIDE", "unii": "NBZ3QY004S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin", "Purpose": "Dimethicone 28%..........Skin protectant White Petrolatum 48%............Skin protectant", "Warnings": "For external use only.", "Directions": "apply as needed", "Questions?": "Toll free (888) 548-0900", "Do not use on": "deep or puncture wounds animal bites serious burns", "Other information": "Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].", "Active Ingredients": "Dimethicone 28% White Petrolatum 48%", "Inactive Ingredients": "aluminum starch octenylsuccinate, fractionated coconut oil, magnesium hydroxide, spearmint oil", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.284386 · Updated: 2026-03-14T23:03:04.544899