MENTHOL AND ZINC OXIDE- menthol and zinc oxide ointment 
ASTONEA LABS PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ASTONEA Tender Calm



Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

Active Ingredients


Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Purpose

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

uses

A moisture barrier that prevents and helps heal skin irritations from;

Warnings:

■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes

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

Keep Out Of Reach Of Children

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

Dosage & Administration:

Inactive Ingredients

Calamine, Glycerine, Lanolin, Light Liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

Principal Display and Drug Fact Panel

MENTHOL AND ZINC OXIDE 
menthol and zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-013
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 OXIDE20.625 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
THYMOL (UNII: 3J50XA376E)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-013-23113 g in 1 TUBE; Type 0: Not a Combination Product08/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/17/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 8/2022
Document Id: e67673ba-333e-6bf6-e053-2a95a90a69fb
Set id: e67673ba-333c-6bf6-e053-2a95a90a69fb
Version: 1
Effective Time: 20220817
 
ASTONEA LABS PRIVATE LIMITED