Search by Drug Name or NDC

NDC 68770-0152-10 Ortho-K Thin 14; 6; 9; 7; 8; 6; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Ortho-K Thin 14; 6; 9; 7; 8; 6; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Ortho-K Thin is a OPHTHALMIC LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Natural Ophthalmics, Inc. The primary component is ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; SULFUR; TRIBASIC CALCIUM PHOSPHATE.

Product Information

NDC	68770-0152
Product ID	68770-152_e33ce1d6-f752-50fb-e053-2995a90ae6fa
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ortho-K Thin
Proprietary Name Suffix	(Daytime)
Non-Proprietary Name	Aluminum Oxide, Apis mellifera, Arsenic Trioxide, Calendula Officinalis Flowering Top, Tribasic Calcium Phosphate, Euphrasia Stricta, Delphinium Staphisagria Seeds, Sulphur
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	OPHTHALMIC
Active Ingredient Strength	14; 6; 9; 7; 8; 6; 9; 12
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	ALUMINUM OXIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; CALENDULA OFFICINALIS FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; EUPHRASIA STRICTA; SULFUR; TRIBASIC CALCIUM PHOSPHATE
Labeler Name	Natural Ophthalmics, Inc
Pharmaceutical Class	Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68770-0152-10 (68770015210)

Pricing Information	N/A
NDC Package Code	68770-152-10
Billing NDC	68770015210
Package	10 mL in 1 BOTTLE, DROPPER (68770-152-10)
Marketing Start Date	2020-07-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa686dba-5f50-e08c-e053-2995a90a4a04 Details

Homeopathic Purpose

Alumina	14x	Dryness of the eyes and other mucous membranes
Apis	6x & 12x	Pain, redness, edema, allergies
Arsenicum album	9x	Severe dryness
Calendula	7x	Corneal healing/vitality
Calcarea phosphorica	12X	Foreign body sensation
Euphrasia (Eyebright)	6x	General dryness, redness and irritation of the eye and lids
Staphysagria	8x & 12x	Foreign body sensation
Sulphur	9x	Dryness, redness of eye and lid, allergies

Active Ingredients

Alumina	14x
Apis	6x & 12x
Arsenicum album	9x
Calendula	7x
Calcarea phosphorica	12X
Euphrasia (Eyebright)	6x
Staphysagria	8x & 12x
Sulphur	9x

"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

Purified water
Polysorbate 80
Sodium citrate
Sodium chloride
Citric acid

Uses

According to homeopathic principles these drops are indicated to relieve dryness, redness, irritation and to promote corneal health.*

*Claims are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Directions

Instill one to three drops in the affected eye(s) as needed.

Warnings

- For ophthalmic use.

- For Professional Use Only

Do not use if tamper evident seal is torn, broken. or missing.

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.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

If pregnant or breast feeding

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

Do not use

Do not use if solution becomes cloudy.

Storage

Safe Storage

Room temperature.

59 o to 86 o (15 o to 30 o C)

SPL UNCLASSIFIED SECTION

Natural Ophthalmics, Inc.

Lafayette, CO 80026 USA

www.natoph.com

877-220-9710

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORTHO-K THIN (DAYTIME)

aluminum oxide, apis mellifera, arsenic trioxide, calendula officinalis flowering top, tribasic calcium phosphate, euphrasia stricta, delphinium staphisagria seeds, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68770-152
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933)	ALUMINUM OXIDE	14 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	9 [hp_X] in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	7 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	12 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	8 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	9 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68770-152-10	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/14/2020

Labeler - Natural Ophthalmics, Inc (118039333)

Revised: 7/2022

Document Id: e33ce1d6-f752-50fb-e053-2995a90ae6fa

Set id: aa686dba-5f50-e08c-e053-2995a90a4a04

Version: 2

Effective Time: 20220707

Search by Drug Name or NDC

NDC 68770-0152-10 Ortho-K Thin 14; 6; 9; 7; 8; 6; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Ortho-K Thin 14; 6; 9; 7; 8; 6; 9; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 68770-0152-10 (68770015210)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL aa686dba-5f50-e08c-e053-2995a90a4a04 Details

Homeopathic Purpose

Active Ingredients

Inactive Ingredients

Uses

Directions

Warnings

Stop use and ask a doctor if:

SPL UNCLASSIFIED SECTION

If pregnant or breast feeding

Do not use

Storage

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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