SAINT- cough spray liquid 
Saint Medicine, Inc.

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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Saint Cough Spray

Active ingredient

Menthol 3.2%

Purpose

Cough Suppressant

Use

To relieve cough, eliminate phlegm, anti-inflammatory, and relieve headache, sore throat, red eyes, throat and lung discomfort symptoms

Suitable for cough caused by the following diseases:

Cold, trachea and bronchitis, pulmonary fibrosis, pulmonary sarcoidosis

Warnings

For external use only

For nebulization inhalation only, do not take orally.

Please keep this product out of the reach of children.

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

Please keep this product out of the reach of children.

Directions

When using this product

Counsult a doctor when using:

Usage

This product has been diluted and accurately dosed in accordance with FDA medication recommendations, 5 ml per vial, and it can be used by inhalation in an atomizer, each vial can be used once, 2-3 times a day.

Choose an atomizer and use it according to the manufacturer's instructions.

It is recommended to use mesh-sieve atomizer, medical-grade products should be selected, and that is product with medical device approval numbers.

Other information:

The product should be stored strictly away from light and should be kept at low temperature.

The total amount is 15.22 ounces (150 ml), including 90 vials, 0.1691 ounces (5ml) per vial.

Inactive ingredient

EGCG, Ginsenosides, N-Acetyl Cysteine, Nattokinase, Medical Purified Water

PRINCIPAL DISPLAY PANEL

72784-101-01

PDP

SAINT 
cough spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72784-101
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
GINSENOSIDES (UNII: 3K198YD54P)  
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
NATTOKINASE (UNII: H81695M5OP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72784-101-0190 in 1 BOX07/20/2023
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/20/2023
Labeler - Saint Medicine, Inc. (081508032)
Establishment
NameAddressID/FEIBusiness Operations
Almil Nutritional Products, Inc.153736301manufacture(72784-101)

Revised: 7/2023
Document Id: 00f8f736-76e8-e38e-e063-6394a90a5bf8
Set id: 00f8f724-87bc-e3f5-e063-6394a90a2eed
Version: 1
Effective Time: 20230721
 
Saint Medicine, Inc.