Label: REDEYE RELIEF- apis mellifera, euphrasia stricta, calcium sulfide, loeselia mexicana whole, pulsatilla vulgaris ointment
- NDC Code(s): 17312-167-13
- Packager: TRP Company
- 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 January 10, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Apis HPUS........................Burning, stinging, itching, watering
Euphrasia HPUS...............Red eyes or lids, itching, burning, watering
Hepar sulphuris HPUS......Redness, stinging, discharge
Hoitzia coccinea HPUS.... Redness, dryness
Pulsatilla HPUS.................Itching, burning, redness, watering - WARNINGS
- PREGNANCY OR BREAST FEEDING
- WARNINGS
- Do not use:
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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” of ointment onto fingertip.
- Gently apply directly to affected area.
- Apply before bedtime.
- Homeopathic remedies may not be effective for everyone. Individual results may vary.
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SPL UNCLASSIFIED SECTION
Other information
- Store at room temperature 15° to 30° C (59° to 86°F)
- Keep tube tightly closed. • 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.
- RedEye ReliefTM Homeopathic Sterile Lubricating Eye Ointment is a homeopathic dilution, for details see www.thereliefproducts.com
- INACTIVE INGREDIENT
- QUESTIONS
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Indications and uses
Uses*
According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Burning • Stinging • Itching • Watering • Red eyes or lids • Sleeplessness • Discharge; 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REDEYE RELIEF
apis mellifera, euphrasia stricta, calcium sulfide, loeselia mexicana whole, pulsatilla vulgaris ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-167 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_X] in 1 g EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 g PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 6 [hp_X] in 1 g LOESELIA MEXICANA WHOLE (UNII: XA8YCV5M3E) (LOESELIA MEXICANA WHOLE - UNII:XA8YCV5M3E) LOESELIA MEXICANA WHOLE 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) LACTOSE (UNII: J2B2A4N98G) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-167-13 1 in 1 PACKAGE 05/28/2018 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/28/2018 Labeler - TRP Company (105185719) Registrant - TRP Company (105185719)