CRACKED HEEL REPAIR BALM- dimethicone cream

Cracked Heel Repair Balm by

Drug Labeling and Warnings

Cracked Heel Repair Balm by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

■ helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■ temporarily protects minor: cuts scrapes burns ■ helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if:

■ conditon worsens ■ symptoms last more than 7 days or clear up and occur again wihtin a few days

Do not use on

■ deep or puncture wounds ■ animal bites ■ serious burns

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.

Directions

■ apply generously to affected area as needed

Inactive ingredients

allantoin, butyrospermum parkii (shea) butter, carbomer, ceteareth-20, cetearyl alcohol, disodium EDTA, glycerin, glyceryl stearate, phenoxyethanol, petrolatum, sodium hydroxide, stearic acid, triethylene glycol, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CRACKED HEEL REPAIR BALM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CARBOMER (UNII: 0A5MM307FC)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
ALLANTOIN (UNII: 344S277G0Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CETEARETH-20 (UNII: YRC528SWUY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-042-00	1 in 1 CARTON	11/03/2025
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/03/2025

Labeler - Delta Brands Inc. (102672008)