Label: ALLERGY EYES DAY AND NIGHT RELIEF PACK DAY AND NIGHT RELIEF PACK- allium cepa, ambrosia, apis, euphrasia, histamine hydrochloricum, sabadilla, sulphur kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 10, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Allergy Eyes Relief ® PM

    Drug Facts

  • Active ingredients

    Allium cepa HPUS 6X

    Ambrosia HPUS 6X

    Apis HPUS 6X

    Euphrasia HPUS 6X

    Histamine hydochloricum HPUS 12X, 18X

    Sabadilla HPUS 6X

    Sulphur HPUS 12X, 18X

    Valeriana officinalis HPUS 6X

    Allium cepa HPUS - Acute eye allergy

    Ambrosia HPUS - Seasonal eye allergy

    Apis HPUS - Redness

    Euphrasia HPUS - Excessive watering, swelling

    Histamine hydochloricum HPUS - Itchiness

    Sabadilla HPUS - Burning

    Sulphur HPUS - Chronic eye allergy

    Valeriana officinalis HPUS - Sleeplessness

  • Uses

    Uses*

    • According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Itchiness • Excessive watering • Redness • Burning • Swelling • Sleeplessness • Acute, chronic, and seasonal eye allergies; 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.

  • Warnings

    Warnings:

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

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

    • 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 TUBE. • The use of this container by more than one person may spread infection.

    Do not use

    • Do not use if bottom ridge of tube cap is exposed and imprinted carton seal is not intact.
    • Do not use if cap or tube is damaged.

    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.
    • The condition last longer than 72 hours.

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

    Keep out of reach of children.

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

  • Directions

    Directions:

    • Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use. • Wash your hands. • Squeeze out approx. 1/8 directly to the eye. • Apply before bedtime. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

  • Other information

    • Store at room temperature 15° to 30° C (59° to 86°F) • Keep tube tightly closed.

  • Inactive ingredients

    Inactive Ingredients:

    Lactose, Lanolin Alcohol, Mineral Oil, White Petrolatum.

  • Questions?

    Questions or Comments?

    888-969-6855

  • 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 or contraindications. • Allergy Eyes Relief® PM Homeopathic Sterile Lubricating Eye Ointment is a homeopathic dilution, for details see www.thereliefproducts.com.

  • SPL UNCLASSIFIED SECTION

    Allergy Eyes Relief®

    Drug Facts

  • Active ingredients

    Allium cepa HPUS 6X

    Ambrosia HPUS 6X

    Apis HPUS 6X

    Euphrasia HPUS 6X

    Histamine hydochloricum HPUS 12X, 18X

    Sabadilla HPUS 6X

    Sulphur HPUS 12X, 18X

    Purpose

    Allium cepa HPUS - Acute eye allergy

    Ambrosia HPUS - Seasonal eye allergy

    Apis HPUS - Redness

    Euphrasia HPUS - Excessive watering, swelling

    Histamine hydochloricum HPUS - Itchiness

    Sabadilla HPUS - Burning

    Sulphur HPUS - Chronic eye allergy

  • Uses

    Uses*

    • According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Itchiness • Excessive watering • Redness • Burning • Swelling • Acute, chronic, and seasonal eye allergies; 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.

  • Warnings

    Warnings

    A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur. • 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 UNOPENED BOTTLE. • The use of this container by more than one person may spread infection.

    Do not use

    Do not use if:

    • • Solution changes color or becomes cloudy.
    • • You frequently contract infections that do not clear up easily.

    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.

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

    Keep out of reach of children.

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

  • Directions

    Directions

    • Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician 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.

  • Other information

    Store at room temperature 15 o to 30 o C (59 o to 86 o F)

    • Keep bottle tightly closed.

  • Inactive ingredients

    Inactive ingredients

    Benzalkonium chloride (preservative), Purified water, Sodium chloride, Sodium phosphate dibasic, Sodium phosphate monobasic.

  • 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 or contraindications. • Allergy Eyes Relief® Homeopathic Sterile Eye Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

  • PRINCIPAL DISPLAY PANEL - Kit Carton

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

    Carton

  • INGREDIENTS AND APPEARANCE
    ALLERGY EYES DAY AND NIGHT RELIEF PACK  DAY AND NIGHT RELIEF PACK
    allium cepa, ambrosia, apis, euphrasia, histamine hydrochloricum, sabadilla, sulphur kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-182
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-182-201 in 1 CARTON; Type 0: Not a Combination Product04/11/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 10 mL
    Part 21 TUBE 4 g
    Part 1 of 2
    ALLERGY EYES RELIEF 
    allium cepa, ambrosia, apis, euphrasia, histamine hydrochloricum, sabadilla, sulphur liquid
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 1 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    ALLIUM CEPA WHOLE (UNII: 8P2VLG2456) (ALLIUM CEPA WHOLE - UNII:8P2VLG2456) ALLIUM CEPA WHOLE6 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 1 mL
    HISTAMINE (UNII: 820484N8I3) (HISTAMINE - UNII:820484N8I3) HISTAMINE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/03/2017
    Part 2 of 2
    ALLERGY EYES RELIEF NIGHTTIME FORMULA 
    allium cepa, ambrosia, apis, euphrasia, histamine hydochloricum, sabadilla, sulphur, valeriana officinalis ointment
    Product Information
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 4 g
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA6 [hp_X]  in 4 g
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 4 g
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA6 [hp_X]  in 4 g
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 4 g
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 4 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2020
    Labeler - TRP Company (105185719)
    Registrant - TRP Company (105185719)