MY MEDIC CALENDULA GEL- calendula officinalis flowers gel 
Sled Distribution, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Calendula Gel

Purpose Section

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

Active Ingredients

Calendula Officinalis Flower Extract ...... 4%

Indications and Usage

temporarily relieve muscle pain and stiffness due to: 

Keep our of Reach of Children

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

Warning Section

Warnings

For external use only.

■ Do not use on if are allergic to Calendula or any of this product's inactive ingredients.

When using this product

■ avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.

■dryness or irritation may occur

Stop use and ask a doctor if

Storange and Handling

Store at room temperature.

Dosage & Administration

apply a thin layer of gel toaffected area as soon as possible after minor injure. Repeat 3 time a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

Inactive Ingredients

White Petroleum, Water

Principal Display Panel

label

MY MEDIC  CALENDULA GEL
calendula officinalis flowers gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81417-126-013.5 g in 1 PACKAGE; Type 0: Not a Combination Product04/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/07/2022
Labeler - Sled Distribution, LLC (079772888)
Establishment
NameAddressID/FEIBusiness Operations
Sled Distribution, LLC079772888manufacture(81417-126)

Revised: 4/2022
Document Id: be234fe2-9047-433f-9fed-09a5e9c1ca35
Set id: 38823385-1929-4a44-8dba-7872f6a8bfd8
Version: 1
Effective Time: 20220407
 
Sled Distribution, LLC