Label: MOM OF 11 KIDS NO TIME FOR DIAPER RASH- calendula, comfrey ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 24909-501-16, 24909-501-85, 24909-501-86, 24909-501-90 - Packager: Aidance Skincare & Topical Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated August 20, 2015
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL - 165g Label
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INGREDIENTS AND APPEARANCE
MOM OF 11 KIDS NO TIME FOR DIAPER RASH
calendula, comfrey ointmentProduct 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)