CALPROTECT- menthol, zinc oxide ointment

Calprotect by

Drug Labeling and Warnings

Calprotect by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astrigent

Uses

A moisture barrier that prevents and helps heal skin irritations from

• urine
• diarrhea
• perspiration
• fistula drainage
• feeding tube site leakage
• wound drainage (per-wound skin)
• minor burns
• cuts
• scrapes
• itching

Warnings

For external use only

• Not for deep or puncture wounds
• Avoid contact with eyes
• Incase of accidental ingestion, contact a physician or posion contril immediately
• If condition worsens or does not improve in 7 days, consult a doctor
• Do not put this product into the rectum by using fingers or any machanical device or applicator
• Children under 12 years of age: consult a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Directions

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Calprotect 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.

Other information

Store between 15-30°C (59-86°F)

Inactive ingredients

calamine, chlorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions or comments?

1-516-341-0666 8:30 am-4:30 pm EST Mon-Fri

PRINCIPAL DISPLAY PANEL

Protects, Soothes & Promotes Healing

NDC: 69618-067-82

Compare to active ingredients in Calmoseptine*

CalProtect Ointment

External use only

Made in the USA

*Reliable-1 Labs is not affiliated with the owner of the registered trademark Calmoseptine

INGREDIENTS AND APPEARANCE

CALPROTECT 
menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-067
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-067-82	113 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021
2	NDC: 69618-067-71	71 g in 1 JAR; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/01/2021

Labeler - Reliable 1 Laboratories LLC (079718111)