Label: PINKEYE RELIEF- aconitum napellus root, apis mellifera, silver nitrate, euphrasia stricta, sodium arsenate dibasic heptahydrate, valerian ointment
- NDC Code(s): 17312-166-13
- 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.
Updated September 10, 2021
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- ACTIVE INGREDIENT
- PREGNANCY OR BREAST FEEDING
- Do not use:
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- 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.
SPL UNCLASSIFIED SECTION
- Non-prescription drug products cannot treat infections.
- 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.
- PinkEye Relief® Homeopathic Sterile Lubricating Eye Ointment is a homeopathic dilution, for details see www.thereliefproducts.com.
- INACTIVE INGREDIENT
Indications and uses
According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Redness • Burning sensations •Watering •Swelling •Sensation of grittiness • Sleeplessness and overnight crusting; 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
INGREDIENTS AND APPEARANCE
aconitum napellus root, apis mellifera, silver nitrate, euphrasia stricta, sodium arsenate dibasic heptahydrate, valerian ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-166 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 SODIUM ARSENATE, DIBASIC HEPTAHYDRATE (UNII: 90ZQ7G407W) (ARSENATE ION - UNII:G1DBI405OK) SODIUM ARSENATE, DIBASIC HEPTAHYDRATE 11 [hp_X] in 1 g VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] in 1 g SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 12 [hp_X] in 1 g ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X) ACONITUM NAPELLUS ROOT 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:17312-166-13 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)