Arniflora

Arniflora
SPL v15
SPL
SPL Set ID 935bf19d-a32c-49b8-a5cc-13e7ddfb23fe
Route
TOPICAL
Published
Effective Date 2025-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 [hp_X])
Inactive Ingredients
Alcohol Carbomer Homopolymer Type C Water Witch Hazel Sodium Hydroxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2011-01-01 Until 2026-05-31

Description

Contains 8% Arnica montana 1X 

Purpose

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries. Reduces pain, swelling, and discoloration from bruises.

Dosage and Administration

Directions Apply thin layer to affected area. Massage gently or use compress. For best results, use promptly after injury or trauma occurs. Adults and children 6 years of age and older: apply to affected area up to 4 times daily. Patch test recommended on sensitive skin.


Medication Information

Purpose

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Dosage and Administration

Directions

Apply thin layer to affected area. Massage gently or use compress.

For best results, use promptly after injury or trauma occurs.

Adults and children 6 years of age and older: apply to affected area up to 4 times daily.

Patch test recommended on sensitive skin.

Description

Contains 8% Arnica montana 1X 

Section 51945-4

Overdose

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

Stop Use

Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be signs of a serious condition.

Warnings

For external use only.

Avoid contact with eyes and broken skin.

Do Not Use

Do not use if hypersensitive to this or any ingredients in this product.

Breast-feeding women should not apply to breast area.

Active Ingredient

Contains 8% Arnica montana 1X 

Indications & Usage

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Inactive Ingredients

Carbomer

Ethyl Alcohol

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Overdose

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

Stop Use

Stop use and ask a doctor if skin irritation, rash, or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and occur again within a few days.

These could be signs of a serious condition.

Warnings

For external use only.

Avoid contact with eyes and broken skin.

Do Not Use

Do not use if hypersensitive to this or any ingredients in this product.

Breast-feeding women should not apply to breast area.

Active Ingredient

Contains 8% Arnica montana 1X 

Indications & Usage

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises.

Inactive Ingredients

Carbomer

Ethyl Alcohol

Purified Water

Sodium Hydroxide

Witch Hazel Distillate

Dosage and Administration

Directions

Apply thin layer to affected area. Massage gently or use compress.

For best results, use promptly after injury or trauma occurs.

Adults and children 6 years of age and older: apply to affected area up to 4 times daily.

Patch test recommended on sensitive skin.

Pregnant Or Breast Feeding (Pregnant or breast feeding)

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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