NDC Code(s) : 11701-066-22, 11701-066-33, 11701-066-32
Packager : Coloplast Manufacturing US, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Critic Aid ClearPetrolatum OINTMENT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11701-066
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM(UNII: 4T6H12BN9U)
(PETROLATUM - UNII:4T6H12BN9U) 		PETROLATUM710 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
DIMETHICONE(UNII: 92RU3N3Y1O)
ZINC OXIDE(UNII: SOI2LOH54Z)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11701-066-224 g in 1 PACKET Type 0: Not a Combination Product15/06/2009
2NDC:11701-066-3371 g in 1 TUBE Type 0: Not a Combination Product15/06/2009
3NDC:11701-066-32170 g in 1 TUBE Type 0: Not a Combination Product15/06/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M016 06/15/2009

LABELER - Coloplast Manufacturing US, LLC(110326675)

REGISTRANT - Coloplast Corp(847436391)

Establishment
Name Address ID/FEI Business Operations
Coloplast Manufacturing US, LLC 110326675 MANUFACTURE(11701-066)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NET WT. 6 OZ. (170 g)

NDC 11701-066-32

Critic-Aid ®Clear

Skin Protectant

Clear Moisture Barrier Ointment

For Minor To Severe

Skin Irritation

Due To Incontinence

Coloplast

NET WT. 6 OZ. (170 g)

PRINCIPAL DISPLAY PANEL - NET WT. 6 OZ. (170 g)