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NDC 57687-0209-10 Bach Original Flower Remedies Crab Apple 5 [hp_X]/.095mL Details

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

Bach Original Flower Remedies Crab Apple is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Nelson Bach USA Limited. The primary component is MALUS PUMILA FLOWER.

Product Information

NDC	57687-0209
Product ID	57687-209_e9aff44b-dabd-6449-e053-2995a90a86c1
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 Crab Apple
Proprietary Name Suffix	n/a
Non-Proprietary Name	Malus pumila
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	[hp_X]/.095mL
Substance Name	MALUS PUMILA FLOWER
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 57687-0209-10 (57687020910)

Pricing Information	N/A
NDC Package Code	57687-209-10
Billing NDC	57687020910
Package	1 BOTTLE, DROPPER in 1 CARTON (57687-209-10) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2022-09-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9aff44b-dabc-6449-e053-2995a90a86c1 Details

Active ingredient

Crab Apple (Malus pumila) 5X HPUS

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

Purpose

Accept imperfections

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 CRAB APPLE

malus pumila solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57687-209
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MALUS PUMILA FLOWER (UNII: EF626V855K) (MALUS PUMILA FLOWER - UNII:EF626V855K)	MALUS PUMILA FLOWER	5 [hp_X] in 0.095 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57687-209-10	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(57687-209)

Revised: 9/2022

Document Id: e9aff44b-dabd-6449-e053-2995a90a86c1

Set id: e9aff44b-dabc-6449-e053-2995a90a86c1

Version: 1

Effective Time: 20220927