81417-007 My Medic Calendula Gel

81417-007 My Medic Calendula Gel
SPL v2
SPL
SPL Set ID e744741b-c992-3b14-e053-2995a90a61d2
Route
TOPICAL
Published
Effective Date 2022-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flower (4 g)
Inactive Ingredients
Water White Petrolatum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-08-29

Description

Calendula Officinalis Flower Extract (4%)

Purpose

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


Medication Information

Purpose

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

Description

Calendula Officinalis Flower Extract (4%)

Uses

temporarily relieve muscle pain and stiffness due to:

  • minor infuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as
  • discoloration
  • pain
  • swelling
Section 50566-9

Stop use and ask a doctor if

  • conditions persist for more than3 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 Calendula or any of this product's inactive ingredients.

Section 51945-4

Section 60561-8

do not use if the sachet seal is broken.

Warnings

For external use only.

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.

Purpose Section

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

Active Ingredients

Calendula Officinalis Flower Extract (4%)

Inactive Ingredients

White Petroleum, Water

Keep Out of Reach of Children

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


Structured Label Content

Uses

temporarily relieve muscle pain and stiffness due to:

  • minor infuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as
  • discoloration
  • pain
  • swelling
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • conditions persist for more than3 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 Calendula or any of this product's inactive ingredients.

Section 51945-4 (51945-4)

Section 60561-8 (60561-8)

do not use if the sachet seal is broken.

Warnings

For external use only.

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.

Purpose Section

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

Active Ingredients (Active ingredients)

Calendula Officinalis Flower Extract (4%)

Inactive Ingredients (Inactive ingredients)

White Petroleum, Water

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)