MOM OF 11 KIDS NO TIME FOR DIAPER RASH- calendula, comfrey 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, Comfrey 1X HPUS

Purpose

Calendula - Healing agent / Skin protectant
Comfrey - Inflammatory relief

Uses

Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash.

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

Change wet and soiled diapers promptly. Cleanse the diaper area, and allow to dry. Apply cream as liberally as necessary.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 165g Label

Mom of 11 Kids™

NO TIME FOR™
Diaper Rash
Safe & Natural is Finally Fast & Effective™
Net Wt. 5.9 oz. (165g)

Jar Label

MOM OF 11 KIDS NO TIME FOR DIAPER RASH 
calendula, comfrey ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G) COMFREY1 [hp_X]  in 100 g
Inactive Ingredients
Ingredient NameStrength
ARGAN OIL (UNII: 4V59G5UW9X)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COTTONSEED OIL (UNII: H3E878020N)  
JOJOBA OIL (UNII: 724GKU717M)  
GARCINIA INDICA FRUIT (UNII: 0Q3R71D98M)  
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
SILVER OXIDE (UNII: 897WUN6G6T)  
WHITE WAX (UNII: 7G1J5DA97F)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24909-501-16165 g in 1 JAR; Type 0: Not a Combination Product
2NDC:24909-501-9090 g in 1 JAR; Type 0: Not a Combination Product
3NDC:24909-501-861 in 1 CAN
3NDC:24909-501-8585 g in 1 TUBE; 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(24909-501) , label(24909-501)

Revised: 8/2015
Document Id: 81b43378-fae0-4582-b082-abf1f255262d
Set id: 45390ff7-c75f-4f32-b53e-378d328b161d
Version: 1
Effective Time: 20150820
 
Aidance Skincare & Topical Solutions, LLC