RUGBY PETROLATUM HYDRATING SKIN PROTECTANT- petrolatum ointment

Rugby Petrolatum Hydrating by

Drug Labeling and Warnings

Rugby Petrolatum Hydrating by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Garcoa, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Petrolatum 42%

Purpose

Skin Protectant

Uses

• Temporarily protects and helps relieve chapped or cracked skin and lips.
• Temporarily protects minor cuts, scrapes, and burns.
• Helps protect from drying effects of wind and cold weather.

Warnings

For external use only

When using this product avoid contact with eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Do not use

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Apply as needed.

Other information

Store at room temperature.

Inactive ingredients

ceresin, lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol.

Questions or comments?

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 454 g Jar Label

NDC: 0536-1143-98

Rugby®

PETROLATUM 42%
HYDRATING OINTMENT

Skin Protectant

Deeply hydrates to relieve dry, cracked,
or irritated skin

Free of fragrances

NET WT
16 OZ (454 g)

INGREDIENTS AND APPEARANCE

RUGBY PETROLATUM HYDRATING  SKIN PROTECTANT
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	420 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Ceresin (UNII: Q1LS2UJO3A)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
Microcrystalline Wax (UNII: XOF597Q3KY)
Mineral Oil (UNII: T5L8T28FGP)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1143-98	454 g in 1 JAR; Type 0: Not a Combination Product	05/31/2018
2	NDC: 0536-1143-97	100 g in 1 JAR; Type 0: Not a Combination Product	05/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	05/31/2018

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc		036464697	MANUFACTURE(0536-1143)