HYDROSEPTINE- zinc oxide, menthol ointment

Hydroseptine by

Drug Labeling and Warnings

Hydroseptine by is a Otc medication manufactured, distributed, or labeled by AKRON PHARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients 

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

Active Ingredients                                        Purpose
Menthol 0.44%...........................External analgesic/anti-itch
Zinc Oxide 20.6%......Skin protectant/anorectal astringent 

Uses

• A moisture barrier that prevents and heals skin irritations from
• urine
• diarrhea
• prespiration
• fistula drainage
• feeding tube site leakage
• wound drainage (peri-wound skin)
• minor burns
• cuts
• scrapes
• itching

Warnings

For external use only

When using this product

• not for deep or punctured wounds
• avoid contact with eyes

Stop use and ask doctor if

• In case of accidental ingestion contact a physician or Poison Control Center right away
• if condition worsens or does not improve within 7 days, consult a doctor

Keep out of reach of children.

Directions

Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

Inactive Ingredients:

Other information store at room temperature 15-30 C (59-86 F)

Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions or Comments? Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROSEPTINE 
zinc oxide, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-6743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHLOROTHYMOL (UNII: LJ25TI0CVT)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-6743-1	100 g in 1 JAR; Type 0: Not a Combination Product	11/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	11/05/2021

Labeler - AKRON PHARMA INC (067878881)