ICY HOT WITH LIDOCAINE NO-MESS- menthol and lidocaine liquid 
Rite Aid Hdgrts Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Icy Hot with Lidocaine No-Mess Applicator

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

1

ICY HOT WITH LIDOCAINE NO-MESS 
menthol and lidocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3788
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-3788-970.8 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2020
Labeler - Rite Aid Hdgrts Corp (014578892)
Registrant - Velocity Pharma LLC (962198409)

Revised: 11/2022
Document Id: edf2e6c4-5449-b813-e053-2a95a90a864d
Set id: b090cdce-d17b-b4ff-e053-2995a90aaa70
Version: 3
Effective Time: 20221120
 
Rite Aid Hdgrts Corp