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
Purpose

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

Description

Calendula Officinalis Flower Extract (4%)

Medication Information

Warnings

For external use only.

Uses

temporarily relieve muscle pain and stiffness due to:

  • minor infuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as
  • discoloration
  • pain
  • swelling
Purpose

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

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.

Inactive Ingredients

White Petroleum, Water

Description

Calendula Officinalis Flower Extract (4%)

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.

Purpose Section

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

Active Ingredients

Calendula Officinalis Flower Extract (4%)

Keep Out 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.

Uses

temporarily relieve muscle pain and stiffness due to:

  • minor infuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as
  • discoloration
  • pain
  • swelling
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.

Inactive Ingredients (Inactive ingredients)

White Petroleum, Water

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.

Purpose Section

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

Active Ingredients (Active ingredients)

Calendula Officinalis Flower Extract (4%)

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:27.275364 · Updated: 2026-03-14T23:16:48.879203