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NDC 00536-1061-39 Rugby Ice Blue 20 mg/g Details

Rugby Ice Blue 20 mg/g

Rugby Ice Blue is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories, Inc.. The primary component is MENTHOL, UNSPECIFIED FORM.

Product Information

NDC	00536-1061
Product ID	0536-1061_7e58d9a5-8cda-4366-b96f-cb15d12aded0
Associated GPIs	90070060004010
GCN Sequence Number	031061
GCN Sequence Number Description	menthol GEL (GRAM) 2 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	48059
HICL Sequence Number	002608
HICL Sequence Number Description	MENTHOL
Brand/Generic	Brand
Proprietary Name	Rugby Ice Blue
Proprietary Name Suffix	External Analgesic
Non-Proprietary Name	MENTHOL, UNSPECIFIED FORM
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/g
Substance Name	MENTHOL, UNSPECIFIED FORM
Labeler Name	Rugby Laboratories, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1061-39 (00536106139)

Pricing Information
NDC Package Code	0536-1061-39
Billing NDC	00536106139
Package	226.8 g in 1 JAR (0536-1061-39)
Marketing Start Date	2015-01-20
NDC Exclude Flag	N
Price Per Unit	0.01251
Pricing Unit	GM
Effective Date	2023-08-23
NDC Description	BLUE 2% GEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 2b65cb6a-4364-4770-b7b9-5c4637edd01a Details

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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)

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

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

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

Ingredient Name	Strength
Inactive Ingredients
Ammonia (UNII: 5138Q19F1X)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (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

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

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

Labeler - Rugby Laboratories, Inc. (079246066)

Registrant - Garcoa, Inc. (036464697)

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

Revised: 1/2022

Document Id: 7e58d9a5-8cda-4366-b96f-cb15d12aded0

Set id: 2b65cb6a-4364-4770-b7b9-5c4637edd01a

Version: 3

Effective Time: 20220112

Search by Drug Name or NDC

NDC 00536-1061-39 Rugby Ice Blue 20 mg/g Details

Rugby Ice Blue 20 mg/g

Product Information

Package

Package Images

NDC 00536-1061-39 (00536106139)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 2b65cb6a-4364-4770-b7b9-5c4637edd01a Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 226.8 g Jar Label

INGREDIENTS AND APPEARANCE

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