GERI PROTECT- petrolatum ointment

Geri Protect by

Drug Labeling and Warnings

Geri Protect by is a Otc medication manufactured, distributed, or labeled by Geritrex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Petrolatum 74%

Purpose

Skin Protectant

Protects skin against chafing and reduces rashes. It helps the skin retain needed moisture, while softening and soothing damaged irritated skin. Protects skin against irritating substances that may come in contact with elbows, heals, hands, and private areas of your body. Now has fragrance free formula for sensitive skin. It assists with the healing 

WARNINGS

WARNING: FOR EXTERNAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS AND PRECAUTIONS

Caution: Avoid eye contact. If contact - flush eyes thoroughly with water. If local sensitivity develops discontinue use.

DOSAGE & ADMINISTRATION

Directions: Clean skin. Apply geri-protect ointment, liberally to affected area 2-4 times daily or more frequently as needed.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe vera, lanolin, mineral oil, Paraffin wax, PCMX Powder, Phenoxyethanol, Sodium Borate, Vitamins A, D, and E, water deionized, Zinc Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GERI PROTECT 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	87.32 g  in 118 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BORATE (UNII: 91MBZ8H3QO)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CHLOROXYLENOL (UNII: 0F32U78V2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-650-04	118 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/31/2015

Labeler - Geritrex LLC (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex LLC		112796248	manufacture(54162-650)