MOM OF 11 KIDS NO TIME FOR DIAPER RASH- calendula, comfrey ointment

Drug Labeling and Warnings

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

MOM OF 11 KIDS NO TIME FOR DIAPER RASH 
calendula, comfrey ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 100 g
COMFREY (UNII: D05HXK6R3G) (COMFREY - UNII:D05HXK6R3G)	COMFREY	1 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-501-16	165 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 24909-501-90	90 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 24909-501-86	1 in 1 CAN
3	NDC: 24909-501-85	85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/10/2015

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture(24909-501) , label(24909-501)