Pranicura II

Product NDC
71831-003
11-digit product format
718310003
Labeler code
71831
Product ID
71831-003_cfa50395-1544-43ac-be86-295bcfb74dfd
Type
HUMAN OTC DRUG
Nonproprietary name
GLYCERIN, KAOLIN, CALAMINE, MENTHOL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
PRANICURA GROUP LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
GLYCERIN; KAOLIN; MENTHOL; ZINC OXIDE
Active strength
25 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71831-003-017183100030160 g in 1 JAR (71831-003-01) 60 g2020-04-150000-00-00NoNoCurrent