SALINE AMPOULES- sodium chloride 0.9% spray

Saline Ampoules by

Drug Labeling and Warnings

Saline Ampoules by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Chloride 0.9%

Purpose

Moisturizer

INDICATIONS & USAGE

This product may be used for conditions in the respiratory passages, nasal cavity or as directed by your healthcare provider.

Warnings

For External Use Only

Not for parenteral administration

When using this product

When using this product a mild and temporary irritation may be experienced at the beginning of use.

Keep out of the reach of children

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

If pregnant or breast feeding

Ask a doctor before use.

Do Not Use

• Same applicator on more than one individual
• If sensitive to any of the components

Directions

For Adults and children 4 years and older. Use as often as needed.

Children under 4 years of age consult a doctor.

Hold vial gently and twist top off

Squeeze vial to dispense

Discard after use

Other information

• Store at controlled room temperature 20º-25ºC (68º-77ºF) and protect from sunlight and sources of heat.
• See bottom of carton for Lot No. and Expiration data
• No Bacteriostatic or other preservatives added

Inactive Ingredients

Purified Water

Questions or Comments

Call 1-888-296-9067

Distributed By

Distributed By

Enjoy Good Health

15900 La Cantera Pkwy Ste 20210

San Antonio, TX 78256

Questions: support@enjoygoodhealth.com

Label

INGREDIENTS AND APPEARANCE

SALINE AMPOULES 
sodium chloride 0.9% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-116-05	60 in 1 CARTON	11/22/2022
1		5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/28/2022

Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)