Search by Drug Name or NDC

NDC 17312-0172-15 Eye Strain Relief 6; 6; 13; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Eye Strain Relief 6; 6; 13; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Eye Strain Relief is a OPHTHALMIC LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by TRP Company. The primary component is CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE.

Product Information

NDC	17312-0172
Product ID	17312-172_e4c3feb9-ee5d-44e5-e053-2995a90a2cb4
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	Eye Strain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	ACONITUM NAPELLUS - APIS MELLIFERA - SILVER NITRATE - EUPHRASIA STRICTA - SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE -
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	OPHTHALMIC
Active Ingredient Strength	6; 6; 13; 6; 6; 8
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	CONIUM MACULATUM FLOWERING TOP; EUPHRASIA STRICTA; PHYSOSTIGMA VENENOSUM SEED; POLYGALA SENEGA ROOT; RUTA GRAVEOLENS FLOWERING TOP; SODIUM CHLORIDE
Labeler Name	TRP Company
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17312-0172-15 (17312017215)

Pricing Information	N/A
NDC Package Code	17312-172-15
Billing NDC	17312017215
Package	1 BOTTLE, DROPPER in 1 PACKAGE (17312-172-15) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2018-08-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 74ae6725-48bc-81a2-e053-2a91aa0a4ab7 Details

Active Ingredients

Conium maculatum HPUS 6x

Euphrasia HPUS 6X

Natrium muriaticum HPUS 8X

Physostigma venenosum HPUS 13X

Ruta graveolens HPUS 6X

Senega officinalis HPUS 6X

“HPUS” indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

SPL UNCLASSIFIED SECTION

Conium maculatum HPUS 6X--Eye fatigue, drooping lids

Euphrasia HPUS 6X--Relaxing, calming, soothing

Natrium muriaticum 8X--Difficulty reading

Physostigma venenosum HPUS 13X--Myopia, difficulty focusing

Ruta graveolens HPUS 6X--Eye strain with headaches

Senega officinalis HPUS 6X--Double vision

SPL UNCLASSIFIED SECTION

Uses:*

According to homeopathic indications these ingredients temporarily relieve minor symptoms such as:

• Eye strain with headache • Double vision • Difficulty focusing • Difficulty reading • Eye fatigue • Sore irritated eyes; after serious causes have been ruled out by a physician.

*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

SPL UNCLASSIFIED SECTION

Warnings:

A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.

For External Use Only.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

• This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur.

Contact lens wearers consult physician prior to using.
To avoid contamination - do not touch tip to any surface.
Replace cap after every use.
Use within 30 days of opening.
EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.
The use of this container by more than one person may spread infection.

Do not use:

If solution changes color or becomes cloudy.
If you frequently contract infections that do not clear up easily.
If you experience eye pain or changes in vision.

Stop use and ask a doctor if:

You experience eye pain, changes in vision, continued redness or irritation of the eye.
The condition worsens.
The condition persists for more than 72 hours.

Keep out of reach of children

• Keep out of reach of children.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Directions:

• Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physican before use. • Squeeze 1-3 drops in the eye. Use several times per day as needed. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

SPL UNCLASSIFIED SECTION

Other information:

Non-prescription drug products cannot treat infections.

Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
Store at room temperature 15° to 30° C (59° to 86° F).
Keep bottle tightly closed

• Eye Strain ReliefTM Homeopathic Sterile Eye Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

SPL UNCLASSIFIED SECTION

Inactive Ingredients:

Benzalkonium Chloride (preservative), Purified water, Sodium Chloride, Sodium Phosphate DiBasic, Sodium Phosphate Monobasic

Questions or comments?

www.thereliefproducts.com, 1-888-969-6855

PRINCIPAL DISPLAY PANEL

FDA Disclaimer: Claims based on traditional homeopathic practice, not medical evidence. Not FDA evaluated.

INGREDIENTS AND APPEARANCE

EYE STRAIN RELIEF

aconitum napellus - apis mellifera - silver nitrate - euphrasia stricta - sodium arsenate, dibasic, heptahydrate - liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17312-172
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 1 mL
PHYSOSTIGMA VENENOSUM SEED (UNII: CJV9E9IIOA) (PHYSOSTIGMA VENENOSUM SEED - UNII:CJV9E9IIOA)	PHYSOSTIGMA VENENOSUM SEED	13 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	8 [hp_X] in 1 mL
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF) (POLYGALA SENEGA ROOT - UNII:M7T6H7D4IF)	POLYGALA SENEGA ROOT	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17312-172-15	1 in 1 PACKAGE	08/27/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/27/2018

Labeler - TRP Company (105185719)

Registrant - TRP Company (105185719)

Revised: 7/2022

Document Id: e4c3feb9-ee5d-44e5-e053-2995a90a2cb4

Set id: 74ae6725-48bc-81a2-e053-2a91aa0a4ab7

Version: 4

Effective Time: 20220727

Search by Drug Name or NDC

NDC 17312-0172-15 Eye Strain Relief 6; 6; 13; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Eye Strain Relief 6; 6; 13; 6; 6; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Product Information

Package

Package Images

NDC 17312-0172-15 (17312017215)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 74ae6725-48bc-81a2-e053-2a91aa0a4ab7 Details

Active Ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Do not use:

Stop use and ask a doctor if:

Keep out of reach of children

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Questions or comments?

PRINCIPAL DISPLAY PANEL

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