GERI PROTECT- petrolatum ointment
Geritrex LLC

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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Geri Protect

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

WARNING: FOR EXTERNAL USE ONLY

Keep out of reach of children

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

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

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

package label

GERI PROTECT
petrolatum ointment

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Geritrex LLC (112796248)

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