RITE AID HOT AND COLD PAIN RELIEF PAIN RELIEVING- lidocaine hcl and menthol cream 
Rite Aid

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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Rite Aid Hot & Cold Pain Relief Cream

Rite Aid Lidocaine-Menthol Pain Relief Cream

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Purposes

Topical anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Avoid contact with eyes

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.
  • do not allow contact with eyes

  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

aloe vera leaf, carbopol 940, cetostearyl alcohol, dimethicone 350, edetate disodium, glycerin, glyceryl monostearate, isopropyl alcohol, phenoxyethanol, polysorbate 60, steareth 2, steareth 21, water

PRINCIPAL DISPLAY PANEL

label

RITE AID HOT AND COLD PAIN RELIEF  PAIN RELIEVING
lidocaine hcl and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4216
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.4 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARETH-2 (UNII: V56DFE46J5)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARETH-21 (UNII: 53J3F32P58)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-4216-11 in 1 CARTON06/01/2022
176.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2022
Labeler - Rite Aid (014578892)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(11822-4216)

Revised: 6/2022
Document Id: e08e67d9-8e88-63a5-e053-2995a90ae9ee
Set id: e08e7c5b-34ba-da8a-e053-2a95a90af497
Version: 1
Effective Time: 20220603
 
Rite Aid