DERMA GRAN BC PERINEAL PROTECTANT- zinc oxide and petrolatum ointment 
McKesson Medical-Surgical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients:

Zinc Oxide 20% Petrolatum 30%


Purpose

Protectant


Uses:

Warnings:

For external use only.

Avoid contact with eyes.

If skin condition worsens or does not improve within 7 days, stop use and consult a physician.


Directions


Other Ingredients:

Bentonite, Dimethiconol/Cyclomethicone, Laurylmethicone copolyol, Magnesium sulfate, Methylparaben, Propylparaben, Sodium chloride, Sorbitan tristearate, Steareth -20, Vitamin A palmitate, Water.


Customer Storage:

Store at a Controlled Room Temperature 15-30o(59-86oF)


Principal Display Panel

MCKESSON

DERMA GRAN BC
PERINEAL PROTECTANT
NDC 68599-6105-3

WITH ZINC PLUS VITAMIN A, BENTONITE AND DIMETHICONE


MFR # 61-ND35
3.5
FL OZ ( 98 g)

yutlitled.jpg
DERMA GRAN BC  PERINEAL PROTECTANT
zinc oxide, petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68599-6105
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 30 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
BENTONITE (UNII: A3N5ZCN45C)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
STEARETH-20 (UNII: L0Q8IK9E08)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68599-6105-3 98 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/12/2013
Labeler - McKesson Medical-Surgical (023904428)
Establishment
Name Address ID/FEI Business Operations
Derma Sciences Canada, Inc. 200564891 manufacture(68599-6105)

Revised: 11/2013
Document Id: e2716b5a-efd4-4ed0-bfa3-1c47010b2f9a
Set id: 7b74791b-3cf9-48c5-8255-7633c10210d5
Version: 1
Effective Time: 20131112
 
McKesson Medical-Surgical