84844-003

84844-003
SPL v1
SPL
SPL Set ID 2522adca-3a26-80ed-e063-6394a90a0d26
Route
topical
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-10-23

Purpose

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

Description

Arnica montana HPUS 7%


Medication Information

Warnings

For external use only,Do not use if you are allergic to dermfree.cream or to any of this product's inactive ingredients

Purpose

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

Directions

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

Inactive Ingredients

purified water,Alcohol, carbomer,sodium hydroxide, Vanillyl butyl ether

Description

Arnica montana HPUS 7%

Principal Display Panel

Use

temporarily relieves muscle pain and stiffness due to:

■minor injuries

■overexertion

■falls reduces symptoms of bruising such as:

■pain ■swelling

■discoloration

Stop Use

ocondition persists for more than 3 days or worsens

osymptoms clear up and occur again within a few days.

Ask Doctor

ocondition persists for more than 3 days or worsens

osymptoms clear up and occur again within a few days.

Do Not Use

if you are allergic to dermfree.cream or to any of this product's inactive ingredients

When Using

this product avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin. use only as directed dryness or irritation may occur

do not tightly wrap or bandage the treated area

do not apply heat or ice to treated area immediately before or after use

Active Ingredient

Arnica montana HPUS 7%

Keep Oot of Reach of Children

if swallowed,get medical help Or contact a poison Control Center right away.


Structured Label Content

Warnings

For external use only,Do not use if you are allergic to dermfree.cream or to any of this product's inactive ingredients

Purpose

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

Directions

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

Inactive Ingredients (Inactive ingredients)

purified water,Alcohol, carbomer,sodium hydroxide, Vanillyl butyl ether

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

temporarily relieves muscle pain and stiffness due to:

■minor injuries

■overexertion

■falls reduces symptoms of bruising such as:

■pain ■swelling

■discoloration

Stop Use

ocondition persists for more than 3 days or worsens

osymptoms clear up and occur again within a few days.

Ask Doctor

ocondition persists for more than 3 days or worsens

osymptoms clear up and occur again within a few days.

Do Not Use (Do not use)

if you are allergic to dermfree.cream or to any of this product's inactive ingredients

When Using

this product avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin. use only as directed dryness or irritation may occur

do not tightly wrap or bandage the treated area

do not apply heat or ice to 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)

if swallowed,get medical help Or contact a poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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