ICY HOT LIDOCAINE NO-MESS- lidocaine hydrochloride liquid

Icy Hot Lidocaine No-Mess by

Drug Labeling and Warnings

Icy Hot Lidocaine No-Mess by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ICY HOT with LIDOCAINE CREAM (MAX)

Drug Facts

Active ingredient

Purpose

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

Use

for the temporary relief of pain

Warnings

For external use only

Flammable

 ■ keep away from heat and open flame.

Do not use

■ in large quantities 

■ on wounds or on irritated or damaged skin

■ with a heating pad

When using this product

■ use only as directed

■ do not bandage tightly

■ avoid contact with eyes and mucous membranes

■ do not expose the area to local heat or to direct sunlight

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ redness is present or excessive skin irritation occurs

■ you experience severe burning 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 12 years of age and older:

        ■ apply a thin layer to affected area every 6 to 8 hours, not more than 3 to 4 times daily

        ■ massage until thoroughly absorbed into skin

        ■ wash hands thoroughly with soap and water after each use

■ children under 12 years of age: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-2, steareth-21, water

333-104

Child-resistant packaging. Close cap tightly after use.

Keep carton as it contains important information.

PRINCIPAL DISPLAY PANEL

Lidocaine 4%
IcyHot
Max

INGREDIENTS AND APPEARANCE

ICY HOT LIDOCAINE NO-MESS 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-1711
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-1711-0	42.5 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2022
2	NDC: 41167-1711-1	70.8 g in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/10/2022

Labeler - Chattem, Inc. (003336013)