RUGBY ICE BLUE EXTERNAL ANALGESIC- menthol, unspecified form gel

Rugby Ice Blue by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredient

Menthol 2.0%

Purpose

Pain relieving gel

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Do not use

• with other topical pain relievers.
• with heating pads or other heating devices.

When using this product

• do not use in or near the eyes.
• do not apply to wounds or damaged skin.
• do not bandage tightly.

Stop use and ask a doctor if

• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
• redness or irritation develops.

If pregnant or breast-feeding ask a health professional before use.

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

Directions

• Clean affected area before applying product.
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
• children under 2 years of age: do not use, consult a doctor.

Other information

• store at room temperature 20 to 25°C (68 to 77°F)
• Keep lid tightly closed.
• Do not use, pour, spill or store near heat or open flame.

Inactive ingredients

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Questions or comments?

1-800-645-2158

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Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

Rugby® NDC: 0536-1061-39

Blue Gel
External Analgesic
Pain Relieving Gel for Minor
Aches and Pains of Muscles
and Joints

COMPARE TO ACTIVE INGREDIENT
IN MINERAL ICE®*

NET WT 8 OZ
(226.8 g)

INGREDIENTS AND APPEARANCE

RUGBY ICE BLUE   EXTERNAL ANALGESIC
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Ammonia (UNII: 5138Q19F1X)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
Cupric Sulfate (UNII: LRX7AJ16DT)
Isopropyl Alcohol (UNII: ND2M416302)
Magnesium Sulfate Anhydrous (UNII: ML30MJ2U7I)
Sodium Hydroxide (UNII: 55X04QC32I)
Thymol (UNII: 3J50XA376E)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1061-39	226.8 g in 1 JAR; Type 0: Not a Combination Product	01/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/20/2015

Labeler - Rugby Laboratories, Inc. (079246066)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(0536-1061)