81417-005 my medic arnica gel

81417-005 my medic arnica gel
SPL v2
SPL
SPL Set ID e73c1186-091a-2c57-e053-2995a90a4b02
Route
topical
Published
Effective Date 2022-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
arnica montana (7 g)
Inactive Ingredients
alcohol carbomer interpolymer type a (allyl sucrose crosslinked) water sodium hydroxide propylene glycol

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2022-08-29

Purpose

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

Description

Arnica montana 7%


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

Uses Temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls 
  • reduces symptoms of bruising such as : discoloration, pain, swelling.
Purpose

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

Dosage and Administration

Directions

Apply a thin layer of gel to 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 ointment.

Description

Arnica montana 7%

Section 50565-1

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9

Stop use and ask a doctor if

  • Conditions persist for more than 3 days or worsens
  • Symptoms clear up and occur again within a few days.
Section 50567-7

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • dryness or irritation may occur
  • use only as directed
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.
Section 50570-1

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

Section 51727-6

Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

Section 51945-4

Section 60561-8

Other information do not use if the sachet seal is broken.

Active Ingredients:

Arnica montana 7%


Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only.

Indications and Usage (34067-9)

Uses Temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls 
  • reduces symptoms of bruising such as : discoloration, pain, swelling.
Purpose

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

Dosage and Administration (34068-7)

Directions

Apply a thin layer of gel to 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 ointment.

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Conditions persist for more than 3 days or worsens
  • Symptoms clear up and occur again within a few days.
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • dryness or irritation may occur
  • use only as directed
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Alcohol, carbomer, purified water, propylene glycol, sodium hydroxide

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

Other information do not use if the sachet seal is broken.

Active Ingredients: (Active ingredients:)

Arnica montana 7%


Advanced Ingredient Data


Raw Label Data

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