MENTHOLATUM HEEL REVIVAL CREAM cream

Mentholatum Heel Revival Cream by

Drug Labeling and Warnings

Mentholatum Heel Revival Cream by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Tolnaftate 1%

Purpose

Tolnaftate - Antifungal

Uses

• proven clinically effective in the treatment of most cracked heel athlete’s foot
• relieves cracking, irritation and discomfort
• prevents the recurrence of most cracked heel athlete's foot with daily use
• Clears up most athlete’s foot infection and with daily use helps keep it from coming back

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product,

avoid contact with the eyes.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Directions

• clean the affected area and dry thoroughly
• apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• for athlete’s foot: pay special attention to the areas between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
• this product is not effective on the scalp or nails

Inactive ingredients

water, caprylic/capric triglyceride, urea, cetyl alcohol, glycerin, glycine, hexadecane, tridecyl stearate, ethoxydiglycol, ceteth-23, polyacrylate crosspolymer-6, diethyl sebacate, dimethicone, hydroxyethylcellulose, lactic acid, phenoxyethanol, propylene glycol caprylate, simmondsia chinensis (jojoba) seed oil, sodium dilauramidoglutamide lysine, sorbitan stearate, squalane, zinc oxide

Questions?

1-877-636-2677 MON-FRI 9AM-5PM (EST)

Keep Out of Reach of Children

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

Drug Facts

Prinicipal Display Panel

INGREDIENTS AND APPEARANCE

MENTHOLATUM HEEL REVIVAL CREAM 
mentholatum heel revival cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINC OXIDE (UNII: SOI2LOH54Z)
GLYCERIN (UNII: PDC6A3C0OX)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)
CETETH-23 (UNII: 495CTZ441V)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIETHYL SEBACATE (UNII: I41B9FJK6V)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXADECANE (UNII: F8Z00SHP6Q)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
CETYL ALCOHOL (UNII: 936JST6JCN)
LACTIC ACID (UNII: 33X04XA5AT)
DIMETHICONE (UNII: 92RU3N3Y1O)
UREA (UNII: 8W8T17847W)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
SQUALANE (UNII: GW89575KF9)
GLYCINE (UNII: TE7660XO1C)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
TRIDECYL STEARATE (UNII: A8OE252M6L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-0020-1	1 in 1 CARTON	09/30/2024
1		28 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	M005	09/12/2024

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	manufacture(10742-0020)