NDC 54291-022-01
API & Excipient Details

marketed by Canadian Custom Packaging Company under NDC Code 54291-022-01

NDC Code(s) : 54291-022-01
Packager : Canadian Custom Packaging Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

12 Hour HealingAllantoin OINTMENT

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:54291-022
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN(UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF(UNII: ZY81Z83H0X)
YELLOW WAX(UNII: 2ZA36H0S2V)
LEVOMENOL(UNII: 24WE03BX2T)
SHEANUT OIL(UNII: O88E196QRF)
COCONUT OIL(UNII: Q9L0O73W7L)
THEOBROMA GRANDIFLORUM SEED BUTTER(UNII: I711F13FXM)
SUNFLOWER OIL(UNII: 3W1JG795YI)
PETROLATUM(UNII: 4T6H12BN9U)
ROSA CANINA FRUIT OIL(UNII: CR7307M3QZ)
JOJOBA OIL(UNII: 724GKU717M)
TOCOPHEROL(UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54291-022-01	102 g in 1 TUBE Type 0: Not a Combination Product	05/02/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/02/2017

PRINCIPAL DISPLAY PANEL

Skinfix_12HR_US_4oz_V6_OL_R