FDA.reportPublic FDA data

Arnica Pain Relief Gel with Aloe

Manufacturer
HomeoCare Laboratories
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:34:50

Label at a glance#

ProductArnica Pain Relief Gel with Aloe
Active ingredientARNICA MONTANA
Label structure10 sections

Dosage and administration

For external use only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a doctor).

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1X HPUS (7%)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe vera, Caprylyl Glycol, Hexylene Glycol, Hydroxyethylcellulose, Phenoxyethanol, Potassium Sorbate, Purified water

Warnings:

WARNINGS SECTION

For external use only. Ask a doctor before use if pregnant or breastfeeding. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a doctor if: Condition worsens, symptoms last more than 7 days, you are allergic to any of the ingredients.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

For external use only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a doctor).

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-888-466-3622 www.homeocare.com

Manufactured & Distributed by:

Homeocare Laboratories, inc.

Yonkers, NY 10701

When using this product:

OTC - WHEN USING SECTION

Do not get into eyes and do not apply on open skin. Stop use and ask a doctor if: Condition worsens, symptoms last more than 7 days, you are allergic to any of the ingredients.

Arnica Pain Relief Gel with Aloe

INDICATIONS & USAGE SECTION

Bruises

Injuries

Muscle Aches

Pain Relief

Pre/Post Surgery

Arnica Pain Relief Gel with Aloe

OTC - PURPOSE SECTION

Bruises

Injuries

Muscle Aches

Pain Relief

Pre/Post Surgery

Arnica Pain Relief Gel with Aloe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica Relief Gel Back Pic.jpgArnica Relief Gel Back Pic.jpg

Arnica Relief Pic.jpgArnica Relief Pic.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-11361727-113-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ARNICA MONTANAO80TY208ZWACTIB
ALOE VERA LEAFZY81Z83H0XIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CAPRYLYL GLYCOL00YIU5438UIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d3bfa34e-8849-5930-e053-2995a90a40067d8ae303-8df4-c46e-e053-2a91aa0a39022021-12-22WarningsExact identifier
spl set id: 7d8ae303-8df4-c46e-e053-2a91aa0a3902

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.