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NDC 76328-0100-00 Ancient Secrets 20 mg/100mL Details

Ancient Secrets 20 mg/100mL

Ancient Secrets is a NASAL AEROSOL, SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by LOTUS BRANDS, INC.. The primary component is SODIUM CHLORIDE.

Product Information

NDC	76328-0100
Product ID	76328-100_fe980cd8-fb02-4042-881e-cdf30fbf2d6d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ancient Secrets
Proprietary Name Suffix	Breathe Again
Non-Proprietary Name	Sodium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, SPRAY
Route	NASAL
Active Ingredient Strength	20
Active Ingredient Units	mg/100mL
Substance Name	SODIUM CHLORIDE
Labeler Name	LOTUS BRANDS, INC.
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 76328-0100-00 (76328010000)

Pricing Information	N/A
NDC Package Code	76328-100-00
Billing NDC	76328010000
Package	1 CANISTER in 1 CARTON (76328-100-00) / 100 mL in 1 CANISTER
Marketing Start Date	2011-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c6d2bab0-d363-4c09-a71b-ae15db915b37 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Chloride 2.0% (Seawater-derived)

Purpose

Restores Moisture

Uses

for nasal rinsing in adults:

Moisturizes and cleanses nasal passages due to pollution, dry air, air conditioning, dust, pollen
Nasal drainage
Helps dry congestion due to colds and allergies

Warnings

For nasal use only.

When using this product

To avoid contamination, do not touch tip of the dispenser to any surface.
Do not use the same dispenser on different people.

Stop use and ask a doctor if you experience any discomfort while using this product.

Keep out of the reach of children.

Directions

Tilt head to one side and forward.

Holding can parallel to the nose, insert nozzle into upper nostril.
Press valve briefly for release of fine mist.

Repeat 2-3 times on each nostril as needed.
Use 2-4 times daily, or as often as necessary.
Use with children ages 6 and older.
Wash carefully with clean warm water and dry carefully after each use.

Other Information

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate.
Store at room temperature (59-86°F).

Inactive Ingredients

purified water

Questions, Comments, Side Effects?

Call toll free 800-824-6396, Monday – Friday, 9:00 – 5:00, CST

SPL UNCLASSIFIED SECTION

Manufactured by

Gerolymatos International S.A.

Athens, Greece

®©2011, Distributed by Lotus Brands, Inc.,

A majority woman-owned family business

1100 Lotus Drive, Silver Lake, WI 53170, USA

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

ANCIENT

SECRETS®

Breathe

Again™

Hypertonic Seawater

Nasal Spray

Sterilized
Helps Dry Congestion

Due to Colds and Allergies
Preservative-Free Saline

3.38 fl.oz. (100 mL)

Principal Display Panel - 100 mL Bottle Carton

INGREDIENTS AND APPEARANCE

ANCIENT SECRETS BREATHE AGAIN

sodium chloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76328-100
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	20 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76328-100-00	1 in 1 CARTON	08/15/2011
1		100 mL in 1 CANISTER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part349	08/15/2011

Labeler - LOTUS BRANDS, INC. (879022713)

Name	Address	ID/FEI	Business Operations
Establishment
GEROLYMATOS INTERNATIONAL SA		506173753	MANUFACTURE(76328-100)

Revised: 10/2018

Document Id: fe980cd8-fb02-4042-881e-cdf30fbf2d6d

Set id: c6d2bab0-d363-4c09-a71b-ae15db915b37

Version: 2

Effective Time: 20181030

Search by Drug Name or NDC

NDC 76328-0100-00 Ancient Secrets 20 mg/100mL Details

Ancient Secrets 20 mg/100mL

Product Information

Package

Package Images

NDC 76328-0100-00 (76328010000)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c6d2bab0-d363-4c09-a71b-ae15db915b37 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this product

Directions

Other Information

Inactive Ingredients

Questions, Comments, Side Effects?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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