Label: D-ACNE- berberis aquifolium, thuja occidentalis, calendula officinalis ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69825-005-01, 69825-005-02 - Packager: Adven Biotech Private Limited
- 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 March 28, 2016
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- DOSAGE & ADMINISTRATION
- WARNINGS
- PURPOSE
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
D-ACNE
berberis aquifolium, thuja occidentalis, calendula officinalis ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69825-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3) THUJA OCCIDENTALIS ROOT 1 [hp_X] in 100 g MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP) (MAHONIA AQUIFOLIUM ROOT - UNII:746TB9VNDP) MAHONIA AQUIFOLIUM ROOT 1 [hp_X] in 100 g CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69825-005-02 1 in 1 BOX 03/28/2016 1 NDC:69825-005-01 30 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 03/28/2016 Labeler - Adven Biotech Private Limited (858029164) Establishment Name Address ID/FEI Business Operations Adven Biotech Private Limited 858029164 relabel(69825-005) , manufacture(69825-005) , repack(69825-005)