ICE BLUE PAIN ALLEVIATING RUB- menthol, unspecified form, methyl salicylate, camphor (natural) gel 
ICE BLUE PAIN ALLEVIATING RUB- menthol, unspecified form, methyl salicylate, camphor (natural) spray 
Lemisol 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 Ingredients

Methyl Salicylate8%

Menthol 5.0%

Camphor 3.0%

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Uses provides temporary relief of minor aches and pains in muscles and joints associated with

Warnings:

For external use only

When using this product use only as directed

  • do not bandage or apply heating pads
  • do not apply to wounds or damaged skin
  • avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

  • condition worsens
  • irritation develops
  • symptoms persist for more than 8 days or clear up and return

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 immediately.

Directions

Adults and children over 12 years:

Apply generously to affected area

Massage until gel is completely absorbed by skin. Repeat as necessary

Children under 12 years: ask a doctor before use

Inactive Ingredients

DMDM Hydantoin, Eucalyptus Globulus Leaf Oil, FD&C Blue No 1, Glycerin, Isopropyl Alcohol, PEG-40 Hydrogenated Castor Oil, Purified Water.

Principal Display Panel – 8 oz Spray Label

Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®
FORTE

Analgesic/ Analgésico

SPRAY

Net Wt. 4 Oz. (118.2 g)e

Principal Display Panel – 8 oz Spray Label

Principal Display Panel – 8 oz Gel Label

Greaseless

SIN GRASA

Rx
Rysell®

ICE
BLUE®

Analgesic/ Analgésico

Gel

Net Wt. 8 Oz. (226.7 g)e

Principal Display Panel – 8 oz Gel Label
ICE BLUE PAIN ALLEVIATING RUB 
menthol, unspecified form, methyl salicylate, camphor (natural) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82988-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.025 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.022 g  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.003 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82988-101-08226.7 g in 1 JAR; Type 0: Not a Combination Product08/31/2022
2NDC:82988-101-16453.5 g in 1 JAR; Type 0: Not a Combination Product08/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2022
ICE BLUE PAIN ALLEVIATING RUB 
menthol, unspecified form, methyl salicylate, camphor (natural) spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82988-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.05 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.08 g  in 1 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Glycerin (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82988-102-04118.2 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/31/2022
Labeler - Lemisol Corporation (040708586)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetics & Cleaners International, LLC. DBA C&C Industries018949897MANUFACTURE(82988-101, 82988-102)

Revised: 8/2022
Document Id: c8b1a1f6-4e27-4e37-b0cd-6171939fd038
Set id: 0238f4aa-6f40-489a-9a09-a6ba2d8080b5
Version: 1
Effective Time: 20220831
 
Lemisol Corporation