TheraICE TM, Menthol, PAIN RELIEF Gel-Roll On, 2.5 fl. oz / 74 mL, Gel, Bottle; 3 bottles each Bag

PAIN RELIEF Gel-Roll On by

Drug Labeling and Warnings

PAIN RELIEF Gel-Roll On by is a Otc medication manufactured, distributed, or labeled by R & Y Group, LLC, Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF GEL-ROLL ON- menthol gel 
R & Y Group, LLC

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TheraICE TM, Menthol, PAIN RELIEF Gel-Roll On, 2.5 fl. oz / 74 mL, Gel, Bottle; 3 bottles each Bag

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic

Uses

■ For temporary relief of minor aches and pains of muscles and joints

Warnings

For External Use Only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive skin

When using this product

■ Avoid contact with eyes or mucous membranes ■ Do not apply to wounds or damaged skin ■ Do not use with other ointments, creams, sprays or liniments ■ Do not apply to irritated skin or if excessive irritation develops ■ Do not bandage ■ Wash hands after use with cool water ■ Do not use with heating pad or device ■ Store in a cool dry place

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

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

■ Adults and children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary

■ Children under 12 years of age: Consult Physician

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

www.theraice.com

Bottle label:

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Bag label:

PAIN RELIEF GEL-ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83016-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FRANKINCENSE (UNII: R9XLF1R1WM)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL 95% (UNII: 7528N5H79B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83016-332-11	3 in 1 BAG	10/27/2023	10/31/2023
1	NDC: 83016-332-01	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	10/27/2023	10/31/2023

Labeler - R & Y Group, LLC (968585765)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(83016-332)

Revised: 10/2023

Document Id: 08fef43a-6fa9-3040-e063-6394a90a6893

34390-5

Set id: 088ccebc-136c-24f7-e063-6394a90a06d9

Version: 2

Effective Time: 20231031