ICY HOT WITH LIDOCAINE NO-MESS- menthol and lidocaine liquid

Icy Hot with Lidocaine No-Mess by

Drug Labeling and Warnings

Icy Hot with Lidocaine No-Mess by is a Otc medication manufactured, distributed, or labeled by Rite Aid Hdgrts Corp, Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ICY HOT with LIDOCAINE NO MESS

Drug Facts

Active ingredients

Lidocaine HCL

Menthol

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

■ on large areas of the body or on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with eyes and mucous membranes

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

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

■ a transient burning sensation may occur upon application but generally disappears in several days

■ avoid applying into skin folds

Stop use and ask a doctor if

■ 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

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 right away.

Directions

adults and children over 12 years:

■ apply a thin layer to affected area not more than 3 to 4 times daily

■ massage into painful area until thoroughly absorbed into skin

■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ICY HOT WITH LIDOCAINE NO-MESS 
menthol and lidocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3788-9	70.8 g in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2020

Labeler - Rite Aid Hdgrts Corp (014578892)

Registrant - Velocity Pharma LLC (962198409)