RUGBY MENTHOL HOT COLD PATCH- menthol patch

Rugby Menthol Hot Cold Patch by

Drug Labeling and Warnings

Rugby Menthol Hot Cold Patch by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Purpose

Topical analgesic

Warnings

For external use only

When using this product

■ use only as directed

■ Rare cases of serious burns have been reported with products of this type

■ don't bandage tightly or use with a heating pad

■ Avoid contact with the eyes and mucous membranes

■Don't apply to wounds or damaged skin

■ do not use at the same time as other topical analgesics

Stop use and consult a doctor

■ condition worsens

■ redness is present

■ irritation develops

■ symptoms persist for more than 7 days or clear up and occur again within a few days

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

Directions Adults and children 12 years of age and over:

• carefully remove backing from patch
• apply sticky side of patch to affected area
• wear one patch up to 8 hours
• repeat as necessary, but no more than 3 times daily
• discard patch after single use
• reseal pouch after opening.
• Children under 12 years of age: consult a physician.

Other safety information

Store at room temperature, not to exceed 86F (30C)

Inactive Ingredients

CMC, dihydroxyaluminum aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions

Call 1-800-645-2158

INDICATIONS & USAGE

Targeted, long-lasting pain relief

Rugby Menthol Cold / Hot Patch

INGREDIENTS AND APPEARANCE

RUGBY MENTHOL HOT COLD PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1332
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	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1332-15	5 in 1 CARTON	07/01/2021
1		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/01/2021

Labeler - RUGBY LABORATORIES (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(0536-1332)