NDC 68770-113 Womens Tear Stimulation

Pulsatilla, Sepia, Euphrasia, Alumina, Arsenicum Album, Nux Mosch, Zincum M

NDC Product Code 68770-113

NDC Product Information

Womens Tear Stimulation with NDC 68770-113 is a a human over the counter drug product labeled by Natural Ophthalmics, Inc. The generic name of Womens Tear Stimulation is pulsatilla, sepia, euphrasia, alumina, arsenicum album, nux mosch, zincum m. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Natural Ophthalmics, Inc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Womens Tear Stimulation Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PULSATILLA VULGARIS 8 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 8 [hp_X]/mL
  • EUPHRASIA STRICTA 5 [hp_X]/mL
  • ALUMINUM OXIDE 14 [hp_X]/mL
  • ARSENIC TRIOXIDE 12 [hp_X]/mL
  • NUTMEG 6 [hp_X]/mL
  • ZINC 11 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Natural Ophthalmics, Inc
Labeler Code: 68770
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-14-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Womens Tear Stimulation Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Homeopathic Purpose

  • Pulsatilla 8x }Sepia 8x }Euphrasia (Eyebright) 5x } Alumina 10x } Dry eyesArsenicum album 12x }Nux mosch 6x }Zincum met 10x }

Active Ingredients

Pulsatilla 8x

Sepia 8x

Euphrasia 5x

Alumina 10x

Arsenicum album 12x

Nux mosch 6x

Zincum m 11x

Inactive Ingredients

Purified water

Polysorbate 80

Sodium citrate

Sodium chloride

Uses

According to homeopathic principles these drops are indicated for Women with acute or chronic dry eyes, often associated with hormone imbalance, Sjogren's or excessive watering secondary to dry eye.

Directions

Instill 1-3 drops in the eye. Use several times per day as needed.

Warnings

For ophthalmic use.

For Professional Use Only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Incase of accidental ingestion, get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If

Stop use and ask a doctor if: You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens. Symptoms last longer than 72 hours.

Do Not Use

Do not use if solution becomes cloudy.

If Pregnant Or Breast Feeding

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

Storage

  • Safe StorageRoom temperature
  • 59
  • O to 86
  • O (15
  • O to 30
  • O C)

Otc - Questions

Natural Ophthalmics, Inc.

Dillon, CO 80435 USA

www.natoph.com

877-220-9710

* Please review the disclaimer below.