MOM OF 11 KIDS NO TIME FOR CUTS, SCRAPES AND BURNS- calendula ointment 
Aidance Skincare & Topical Solutions, 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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Drug Facts

Active Ingredients

Calendula 1X HPUS

Purpose

Calendula - Healing agent

Uses

Promotes healing from minor cuts, scrapes, burns and skin irritations.

Warnings

For external use only. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. When using this product avoid contact with eyes.

Keep out of reach of children.

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

Directions

Apply a thin layer to clean, dry skin up to 3 times daily. Cover with sterile bandage. Continue until skin improves.

Inactive Ingredients

Beeswax (organic), Chamomile Oil, Cotton Seed Oil, Jojoba Seed Oil (golden), Kokum Butter, Magnesium Oxide, Silver Oxide, Zinc Oxide.

PRINCIPAL DISPLAY PANEL - 30g Label

Mom of 11 Kids™

NO TIME FOR™
Cuts, Scrapes & Burns
Advanced First Aid Ointment
Safe & Natural is Finally Fast & Effective™
Net Wt. 1.1 oz. (30g)

Jar Label

MOM OF 11 KIDS NO TIME FOR CUTS, SCRAPES AND BURNS 
calendula ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-509
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER6 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
GARCINIA INDICA FRUIT (UNII: 0Q3R71D98M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
SILVER OXIDE (UNII: 897WUN6G6T)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-509-3030 g in 1 JAR; Type 0: Not a Combination Product
2NDC:24909-509-1818 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/10/2015
Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
Establishment
NameAddressID/FEIBusiness Operations
Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-509) , label(24909-509)

Revised: 8/2015
Document Id: 4d104246-0241-403d-a5bd-f384ca8e1adf
Set id: b5899d15-291d-4463-8c31-22ef6a72ef38
Version: 1
Effective Time: 20150820
 
Aidance Skincare & Topical Solutions, LLC