HYDRATE LUBRICANT- polyethylene glycol 400 and propylene glycol solution/ drops

HYDRATE Lubricant by

Drug Labeling and Warnings

HYDRATE Lubricant by is a Otc medication manufactured, distributed, or labeled by Sproose Products Inc., Samson Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purposes
Polyethylene glycol 400 0.04%	Lubricant
Propylene glycol 0.3%	Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• to avoid contamination do not touch tip of container to any surface
• replace cap after each use
• remove contacts before using

Stop use and ask a doctor if you experience any of the following

• eye pain
• changes in vision
• continued redness or irritation of the eye
• the condition worsens or persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before using
• Instill 1 or 2 drops in the affected eye(s) as needed

Other information

store at 15°-30°C (59°-86°F)

Inactive Ingredients

Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

866-778-0043 Alchemy43.com

SPL UNCLASSIFIED SECTION

Distributed by
Sproose Products Inc.
West Hollywood, CA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

ALCHEMY 43

HYDRATE

LUBRICANT
EYE DROPS

STERILE 0.5 FL. OZ (15mL)

INGREDIENTS AND APPEARANCE

HYDRATE LUBRICANT 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83716-6000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.004 g  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.003 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83716-6000-1	1 in 1 CARTON	09/01/2023
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M018	09/01/2023

Labeler - Sproose Products Inc. (119019937)

Establishment
Name	Address	ID/FEI	Business Operations
Samson Pharmaceuticals Inc.		088169581	MANUFACTURE(83716-6000)