85248-026

85248-026
SPL v1
SPL
SPL Set ID 49911392-e55e-1a6b-e063-6394a90a9af0
Route
topical
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (7 g)
Inactive Ingredients
water vanillyl butyl ether sodium hydroxide carbomer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-30

Purpose

Relieves muscle pain & stiffness,swelling from injuries, discoloration from bruises

Description

Arnica montana HPUS 7%


Medication Information

Warnings

For external use only

Purpose

Relieves muscle pain & stiffness,swelling from injuries, discoloration from bruises

Directions

Apply a thin layer of arnica bruise cream to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.lf heat or ice is applied, wait 5 minutes before applying arnica bruise cream.

Inactive Ingredients

Purified water,Carbomer.Sodium Hydroxide, Vanilly Butyl Ether

Description

Arnica montana HPUS 7%

Principal Display Panel

Use

Temporarily relieves muscle pain and stiffness due to: ·cminor injuries ·overexertion ·falls Reduces symptoms of bruising such as: ·Pain·Swelling ·discoloration

Stop Use

Condition persists for more than 3 days or worsens, Symptoms clear up and occur again within a few days.

Ask Doctor

Condition persists for more than 3 days or worsens, Symptoms clear up and occur again within a few days.

Do Not Use

Do not use if you are allergic to arnica bruise cream or to any of this product's inactive ingredients.

When Using

When using this product avoid contact with eyes, mucous membranes, wounds,damaged or irritated skin.Use only as directed .Stop use if excessive skin irritation occurs.

Do not tightly wrap or bandage the treated area. Do not apply heat or ice to the treated area immediately before or after use.

Active Ingredient

Arnica montana HPUS 7%

Keep Oot of Reach of Children

lf swallowed, get medical help or contact a Poison control center right away.


Structured Label Content

Warnings

For external use only

Purpose

Relieves muscle pain & stiffness,swelling from injuries, discoloration from bruises

Directions

Apply a thin layer of arnica bruise cream to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed.lf heat or ice is applied, wait 5 minutes before applying arnica bruise cream.

Inactive Ingredients (Inactive ingredients)

Purified water,Carbomer.Sodium Hydroxide, Vanilly Butyl Ether

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

Temporarily relieves muscle pain and stiffness due to: ·cminor injuries ·overexertion ·falls Reduces symptoms of bruising such as: ·Pain·Swelling ·discoloration

Stop Use

Condition persists for more than 3 days or worsens, Symptoms clear up and occur again within a few days.

Ask Doctor

Condition persists for more than 3 days or worsens, Symptoms clear up and occur again within a few days.

Do Not Use (Do not use)

Do not use if you are allergic to arnica bruise cream or to any of this product's inactive ingredients.

When Using

When using this product avoid contact with eyes, mucous membranes, wounds,damaged or irritated skin.Use only as directed .Stop use if excessive skin irritation occurs.

Do not tightly wrap or bandage the treated area. Do not apply heat or ice to the treated area immediately before or after use.

Active Ingredient

Arnica montana HPUS 7%

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

lf swallowed, get medical help or contact a Poison control center right away.


Advanced Ingredient Data


Raw Label Data

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