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.

100mg

HYDROSEPTINE
zinc oxide, menthol ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - AKRON PHARMA INC (067878881)

MEDPURAHydroseptine OintmentProtects, Soothes, Helps Promote Healing