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NDC 00363-0139-26 Arnica gel 1 [hp_X]/g Details

Arnica gel 1 [hp_X]/g

Arnica gel is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREENS. The primary component is ARNICA MONTANA.

Product Information

NDC	00363-0139
Product ID	0363-0139_c7171929-a9a4-5078-e053-2995a90a560e
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	Arnica gel
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	[hp_X]/g
Substance Name	ARNICA MONTANA
Labeler Name	WALGREENS
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 00363-0139-26 (00363013926)

Pricing Information	N/A
NDC Package Code	0363-0139-26
Billing NDC	00363013926
Package	74 g in 1 PACKAGE (0363-0139-26)
Marketing Start Date	2021-07-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b60f9c58-9908-6184-e053-2a95a90aa435 Details

Drug facts

Active ingredient

Arnica montana

1X HPUS 7%

Inactive ingredients

Alcohol, Carbomer, Purified water, Sodium Hydroxide

Dosage and administration

Apply a thin layer of gel to affected area and massage gently as soon as possible after minor injury. Repeat 3 times a day or as needed.

Uses*

temporarily relieves muscel pain and stiffness due to minor injuries, over exertion and falls
reduces pain, swelling and discoloration from bruises

Warnings

For external use only. Avoid contact with eyes, mucous membranes, damaged skin, or wounds.

Do not use if you are allergic to Arnica montana or to any of thus product's inactive ingredients.

When using this product

use only as directed
do not bandage tightly or use a heating pad.

Stop use and ask a doctor if condition persists for more than 3 days or worsens.

keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Trauma, muscle pain, and, stiffness, swelling from injuries, discoloration from bruising

Other information

Do not use if glued carton end flaps are open or if the tube seal is broken,
Store at 68-77 F (20-25 C)

Questions or comments?

1-800-925-4733

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARNICA GEL

arnica gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0139
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0139-26	74 g in 1 PACKAGE; Type 0: Not a Combination Product	07/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/15/2021

Labeler - WALGREENS (008965063)

Revised: 7/2021

Document Id: c7171929-a9a4-5078-e053-2995a90a560e

Set id: b60f9c58-9908-6184-e053-2a95a90aa435

Version: 2

Effective Time: 20210715