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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 4%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

Temporary relief from minor aches and pains of sore muscles and joints

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 bandage tightly or use with heating pad or device
• Avoid contact with eyes
• Do not apply to wounds or damaged skin

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
• if the package arrives damagedor opened
• at the same time as other topical analgesics
• on mucous membrances, cuts, broken, swollen, or irritated skin

DO NOT USE

Do not use

• if you are allergic to the listed ingredients
• if the package arrives damagedor opened
• at the same time as other topical analgesics
• on mucous membrances, cuts, broken, swollen, or irritated skin

STOP USE

Stop Use and Ask a Doctor

if condition worsens, or if syptoms persist for more than 7 days or clear up and occur again within a few days.

if you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering

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

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Arnica Montana Flower Extract, Boswellia Serrata Extrac, Calendula Officinalis Flower Extract,  Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, IsopropyI Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, 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: 84992-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
CAMPHOR, (-)- (UNII: 213N3S8275)
CARBOMER 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84992-001-01	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2025
2	NDC: 84992-001-02	1 in 1 CASE	01/05/2025
2		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 84992-001-03	2 in 1 CASE	01/05/2025
3		74 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 84992-001-04	3 in 1 CASE	01/05/2025
4		74 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	01/04/2025

Labeler - ADP Health Limited (101747972)