ROCKSAUCE ICY COLD PAIN RELIEF- menthol gel

RockSauce ICY COLD PAIN RELIEF by

Drug Labeling and Warnings

RockSauce ICY COLD PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Implus Footcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol6%

PURPOSE

Topical Analgesic

USES:

Provides soothing cold to sore muscles and joints.

WARNINGS:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

When using this product, do not:

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

DO NOT USE

Do not use otherwise than as directed.

ASK DOCTOR

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

Keep out of reach of children:

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

DIRECTIONS:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to 77 ℉(20° to 25℃).

INACTIVE INGREDIENTS:

Aloe Barbadensis(Aloe Vera) Leaf Juice, Arctium Lappa(Burdock)Root Extract, Arnica Montana Flower Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Water, Camellia Sinensis(Green Tea) Leaf Extract, Cinnamomum Camphora Bark Oil, Ethyl Alcohol, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Maltodextrin, Triethanolamine, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROCKSAUCE ICY COLD PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81683-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8.3 g  in 88.5 mL

Inactive Ingredients
Ingredient Name	Strength
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR OIL (UNII: 75IZZ8Y727)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL (UNII: 3K9958V90M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81683-003-01	88.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/18/2021

Labeler - Implus Footcare, LLC (361531585)