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NDC 57687-0214-10 Bach Original Flower Remedies Holly 5 [hp_X]/.095mL Details

Bach Original Flower Remedies Holly 5 [hp_X]/.095mL

Bach Original Flower Remedies Holly is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Nelson Bach USA Limited. The primary component is ILEX AQUIFOLIUM FLOWERING TOP.

Product Information

NDC	57687-0214
Product ID	57687-214_e9d6d33a-2f49-1d4a-e053-2a95a90a2bcf
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	Bach Original Flower Remedies Holly
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ilex aquifolium
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	[hp_X]/.095mL
Substance Name	ILEX AQUIFOLIUM FLOWERING TOP
Labeler Name	Nelson Bach USA Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 57687-0214-10 (57687021410)

Pricing Information	N/A
NDC Package Code	57687-214-10
Billing NDC	57687021410
Package	1 BOTTLE, DROPPER in 1 CARTON (57687-214-10) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2022-09-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9d6d33a-2f48-1d4a-e053-2a95a90a2bcf Details

Active ingredient

Holly (Ilex aquifolium) 5X HPUS

‘HPUS’ indicates the ingredient is in the official Homeopathic Pharmacopoeia of the United States

Purpose

Goodwill towards others

Use

For relief of naturally occurring simple nervous tension

Warnings

Consult a doctor if symptoms last for more than 7 days or worsen.

Keep out of reach of children.

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

Directions

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.

Children under 2: ask a doctor before use.

Other information

Store below 77 ºF (25 ºC)

Do not use if tamper evident seal around bottle neck is missing or broken

Inactive ingredients

glycerin [vegetable], purified water

Questions

800-319-9151 8am-5pm (EST) Mon-Fri

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACH ORIGINAL FLOWER REMEDIES HOLLY

ilex aquifolium solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57687-214
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ILEX AQUIFOLIUM FLOWERING TOP (UNII: 5ENR9SAN1W) (ILEX AQUIFOLIUM FLOWERING TOP - UNII:5ENR9SAN1W)	ILEX AQUIFOLIUM FLOWERING TOP	5 [hp_X] in 0.095 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57687-214-10	1 in 1 CARTON	09/20/2022
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		09/20/2022

Labeler - Nelson Bach USA Limited (877720193)

Registrant - A. Nelson & Co. Limited (221471234)

Name	Address	ID/FEI	Business Operations
Establishment
A. Nelson & Co. Limited		221471234	manufacture(57687-214)

Revised: 9/2022

Document Id: e9d6d33a-2f49-1d4a-e053-2a95a90a2bcf

Set id: e9d6d33a-2f48-1d4a-e053-2a95a90a2bcf

Version: 1

Effective Time: 20220929