ANCIENT SECRETS BREATHE AGAIN- sodium chloride aerosol, spray

Ancient Secrets by

Drug Labeling and Warnings

Ancient Secrets by is a Otc medication manufactured, distributed, or labeled by LOTUS BRANDS, INC., GEROLYMATOS INTERNATIONAL SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	08/15/2011

Labeler - LOTUS BRANDS, INC. (879022713)

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