OTC Medication Information: PrimaGuard Daily Care Skin Protectant

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.

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.

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

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PRIMAGUARD DAILY CARE SKIN PROTECTANT
lanolin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75904-3343
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 300 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
EDETATE DISODIUM
LANOLIN ALCOHOLS
MINERAL OIL
OXYQUINOLINE
PETROLATUM
WATER
SODIUM BORATE
SORBITAN SESQUIOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75904-3343-4 5 g in 1 POUCH None
2 NDC:75904-3343-5 113 g in 1 TUBE None
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 Operations
Summit Industries, Inc. 003279189 manufacture (75904-3343)

Revised: 03/2013 First Choice Medical Supply

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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