PRIMAGUARD DAILY CARE SKIN PROTECTANT- lanolin ointment

PrimaGuard by

Drug Labeling and Warnings

PrimaGuard by is a Otc medication manufactured, distributed, or labeled by First Choice Medical Supply, Summit Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

• Helps prevent and treat skin irritations.
• Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

Warnings: FOR EXTERNAL USE ONLY

• Avoid contact with eyes.
• Do not apply to deep or puncture wounds.
• If condition worsens, or does not improve within 7 days, consult a doctor.
• If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

• KEEP OUT OF REACH OF CHILDREN.

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

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.jpg

INGREDIENTS AND APPEARANCE

PRIMAGUARD  DAILY CARE SKIN PROTECTANT
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75904-3343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75904-3343-4	5 g in 1 POUCH
2	NDC: 75904-3343-5	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/28/2011

Labeler - First Choice Medical Supply (117734405)

Registrant - Summit Industries, Inc. (003279189)

Establishment
Name	Address	ID/FEI	Business Operations
Summit Industries, Inc.		003279189	manufacture(75904-3343)