MENTHOL AND ZINC OXIDE- menthol and zinc oxide ointment 
Dynarex Corporation

----------

1271 Calasoothe Ointment NDC 67777-234-01
1275 Calasoothe Ointment NDC 67777-234-03

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

Purpose


External Analgesic

Skin Protectant

Uses

• A moisture barrier that prevents and helps heal skin irritations from:

• Urine • Diarrhea • Perspiration • 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

• Avoid contact with eyes

Do not use section

• On deep or puncture wounds

Stop use and ask a doctor if

• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Cleanse skin with mild skin cleanser.

• Pat dry or allow to air dry.

• Apply a thin layer of Calasoothe 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 at room temperature 15º-30º C (59º-86º F)

• Tamper evident. Do not use if packet is torn or cut. Do not use if seal is damaged.

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin

Questions?

1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

Label

1275 IN MASTERCalasoothe 4 oz. tube

Label

1271 BX MASTER1271 Calasoothe

Label

1271 BX STIS0101271 Calasoothe

MENTHOL AND ZINC OXIDE 
menthol and zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-234
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOL (UNII: 339NCG44TV)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-234-012 in 1 CASE05/11/2010
1NDC:67777-234-02144 in 1 BOX
13.5 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:67777-234-0324 in 1 CASE05/11/2010
2NDC:67777-234-04113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/11/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 11/2024
Document Id: 2758f00d-dee3-2463-e063-6294a90a53c2
Set id: d0e43651-4215-465b-9ace-1bc23126b109
Version: 13
Effective Time: 20241120
 
Dynarex Corporation