RITE AID HOT AND COLD EXTRA STRENGTH- menthol, methyl salicylate cream 
Rite Aid Corporation

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.

----------

Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

•
simple backache
•
arthritis
•
muscle strains
•
bruises
•
muscle sprains

Warnings

For external use only

When using this product

•
use only as directed
•
do not get into eyes or on mucous membranes
•
do not apply to wounds or irritated or damaged skin
•
do not bandage tightly
•
do not use with a heating pad or apply external heat

Stop use and ask a doctor if

•
skin redness or excessive irritation of the skin occurs
•
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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•
adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
•
children under 12 years: ask a doctor

Inactive Ingredients

glyceryl stearate, isoceteth-20, poloxamer 407, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Principal Display Panel

Rite Aid Hot and Cold
RITE AID HOT AND COLD  EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7958
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOCETETH-20 (UNII: O020065R7Z)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-7958-71 in 1 CARTON06/19/2020
185 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 finalpart34806/19/2020
Labeler - Rite Aid Corporation (014578892)

Revised: 4/2020
Document Id: 9fb3eb7d-9379-4edb-afd6-e5c173b68e82
Set id: 9fb3eb7d-9379-4edb-afd6-e5c173b68e82
Version: 1
Effective Time: 20200427
 
Rite Aid Corporation