PRIMAGUARD DAILY CARE SKIN PROTECTANT- lanolin ointment 
First Choice Medical Supply

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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PrimaGuard Daily Care Skin Protectant Drug Facts

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

Warnings: FOR EXTERNAL USE ONLY

Directions

Gently cleanse and dry area. Apply liberally to affected area as needed.

Other Information

Store at 20-25°C (68-77°F)

Inactive ingredients:

Beeswax (yellow wax), Disodium EDTA, Fragrance, Lanolin Alcohol, Mineral Oil, Oxyquinoline, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions or comments?

Call 800-809-4556

or visit www.fcms

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

Images of representative container artwork

PrimaGuardProtectTubeLabel.jpgTube

PRIMAGUARD  DAILY CARE SKIN PROTECTANT
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75904-3343
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
MINERAL OIL (UNII: T5L8T28FGP)  
OXYQUINOLINE (UNII: 5UTX5635HP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75904-3343-45 g in 1 POUCH
2NDC:75904-3343-5113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/28/2011
Labeler - First Choice Medical Supply (117734405)
Registrant - Summit Industries, Inc. (003279189)
Establishment
NameAddressID/FEIBusiness Operations
Summit Industries, Inc.003279189manufacture(75904-3343)

Revised: 3/2013
Document Id: 7ea32c8e-f745-4325-a0c2-a891f0f7f55f
Set id: 1ce5b0a9-092d-4ab7-b7b7-3104ba0b27d2
Version: 2
Effective Time: 20130321
 
First Choice Medical Supply