Topcare Health Ultra Itch Relief Astringent Eye Drops: Package Insert and Label Information

TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS- tetrahydrozoline hydrochloride and zinc sulfate solution
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purposes

Tetrahydrozoline HCl………..Redness reliever

Zinc sulfate……….Astringent

Use

  • for temporary relief of discomfort and redness of the eye due to minor eye irritations

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 chloride, sodium citrate

carton
(click image for full-size original)

TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS
tetrahydrozoline hcl, zinc sulfate solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-855
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 mL
ZINC SULFATE (ZINC CATION) ZINC SULFATE 0.25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
WATER
SODIUM CHLORIDE
BENZALKONIUM CHLORIDE
EDETATE DISODIUM (EDETIC ACID)
SODIUM CITRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-855-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (36800-855-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 02/01/2020
Labeler — Topco Associates LLC (006935977)
Registrant — K.C. Pharmaceuticals, Inc. (174450460)
Establishment
Name Address ID/FEI Operations
K.C. Pharmaceuticals, Inc. 174450460 manufacture (36800-855), pack (36800-855), label (36800-855)

Revised: 02/2020 Topco Associates LLC

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