AVCOO PAIN RELIEF ROLL ON- menthol cream

AVCOO Pain Relief Roll On by

Drug Labeling and Warnings

AVCOO Pain Relief Roll On by is a Otc medication manufactured, distributed, or labeled by ADP Health Limited, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 10%

Methyl Salicylate: 20%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

Temporary relief from minor aches and pains of sore muscles and joints associatedly with:

simple backaches, arthritis, strains, bruises, and sprain

WARNINGS

Warnings

• Please read all directions and warnings as follows and use only as directed. For external use only.
• Flammable:Keep away from excessive heat and open flame
• Do not heat or microwave
• Do not add to hot water or any container with heated water, as it may cause splattering and resultin burns
• Do not bandage tightly
• Avoid contact with eyes
• For sensitive skins, use with caution
• So not squeeze the bottle during application

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY

If pregnant or breast-feeding,ask a healthcare professional before use

DO NOT USE

Do not use

• if you are allergic to the listed ingredients
• with a heating pad
• on mucous membrances, cuts, broken, swollen, or irritated skin

STOP USE

Stop Use and Ask a Doctor

• if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering
• if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

DOSAGE & ADMINISTRATION

Directions 

• Rub a thin film over the affected area no more than 3-4 times daily
• Wash hands after use with cold water
• Children under 12 years of age: do not use, consult a doctor

STORAGE AND HANDLING

Other Information

• store in a dry place at room temperature between 20-25C (77-86F) and away from direct sunlight

INACTIVE INGREDIENT

Inactive ingredients

Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVCOO PAIN RELIEF ROLL ON 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84992-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPSAICIN (UNII: S07O44R1ZM)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84992-002-01	88.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2025
2	NDC: 84992-002-02	1 in 1 CASE	02/18/2025
2		88.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 84992-002-03	2 in 1 CASE	02/18/2025
3		88.5 mL in 1 BOTTLE; 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	02/18/2025

Labeler - ADP Health Limited (101747972)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(84992-002)