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NDC 71880-0002-01 Healexir 1 [hp_M]/mL Details

Healexir 1 [hp_M]/mL

Healexir is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Healexir, LLC. The primary component is ARNICA MONTANA.

Product Information

NDC	71880-0002
Product ID	71880-0002_07597c35-f192-454d-8ef7-0757ba492a88
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	Healexir
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica Montana
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	[hp_M]/mL
Substance Name	ARNICA MONTANA
Labeler Name	Healexir, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71880-0002-01 (71880000201)

Pricing Information	N/A
NDC Package Code	71880-0002-1
Billing NDC	71880000201
Package	30 mL in 1 BOTTLE, SPRAY (71880-0002-1)
Marketing Start Date	2019-08-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c73fec9a-c422-4e60-b467-ba2276b4dd78 Details

ACTIVE INGREDIENTS:

Arnica Montana 1M.

PURPOSE:

May relieve symptoms associated with temporary bruising and swelling as a result of cosmetic injections.**

**Statements are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

•Consult a physician if symptoms persist

•Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

•Use only as directed.

•Do not use if you have an allergy to any of the ingredients listed.

•If pregnant or nursing, ask a doctor prior to use of product.

•Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

•Store at room temperature.

KEEP OUT OF REACH OF CHILDREN:

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

•Spray single pump into mouth at these intervals:

•Take every 15 minutes (while awake) for first 48 hours following procedure.

•Take every hour (while awake) for the next 48 hours.

•Take every 2 hours for the following 5 days.

•Take 3 times a day for the next 5 days.

•Consult a physician for use in children under 12 years of age.

INDICATIONS:

May relieve symptoms associated with temporary bruising and swelling as a result of cosmetic injections.**

**Statements are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

20% Organic Alcohol v/v, Purified water

QUESTIONS:

Distributed by

Healexir, LLC.

Santa Fe, New Mexico 87505

www.healexir.com 917-568-7777

PACKAGE LABEL DISPLAY:

HEALEXIR

holistic recovery

Homeopathic

1 fluid ounce (30ml)

INGREDIENTS AND APPEARANCE

HEALEXIR

arnica montana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71880-0002
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_M] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71880-0002-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/30/2019

Labeler - Healexir, LLC (080874306)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(71880-0002) , api manufacture(71880-0002) , label(71880-0002) , pack(71880-0002)

Revised: 8/2019

Document Id: 07597c35-f192-454d-8ef7-0757ba492a88

Set id: c73fec9a-c422-4e60-b467-ba2276b4dd78

Version: 1

Effective Time: 20190830