TOPCARE HEALTH ADVANCED MOISTURIZING PLUS REDNESS RELIEF- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution 
Topco Associates LLC

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TopCare Health Advanced Moisturizing Plus Redness Relief (PLD)

Active ingredients

Dextran 70 0.1%

Polyethylene glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.05%

Purposes

Dextran 70... Lubricant

Polyethylene glycol 400... Lubricant

Povidone... Lubricant

Tetrahydrozoline HCl... Redness reliever

Uses

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop use and ask a doctor if you experience

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

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

carton

TOPCARE HEALTH ADVANCED MOISTURIZING PLUS REDNESS RELIEF 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-856
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE1 g  in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4001 g  in 100 mL
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 700.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-856-011 in 1 CARTON02/04/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01802/04/2020
Labeler - Topco Associates LLC (006935977)
Registrant - K.C. Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460manufacture(36800-856) , pack(36800-856) , label(36800-856)

Revised: 12/2023
Document Id: 0cfa88e0-a3dd-180c-e063-6294a90ae2ac
Set id: 9c6193a6-d822-1b27-e053-2995a90ab3cf
Version: 3
Effective Time: 20231220
 
Topco Associates LLC