LIGHTNING PAIN RELIEF- menthol cream 
Clinical Resolution Laboratory, Inc.

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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Lightning Pain Relief Cream

DRUG FACTS

Active Ingredients

Menthol 4%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains.

Warnings

(For external use only)

Do not use this product if

  • tamper-evident "Do not use this product" if safety seal is broken or missing. 
  • pregnant or breastfeeding, ask a health professional before use.

When using this product

  • avoid contact with the eyes or mucous membranes 
  • do not use with other ointments, creams, sprays or liniments
  • do not apply to irritated skin or if excessive irritation develops
  • do not apply to wounds or damaged skin 
  • do not use with heating pad or device 
  • do not bandage

Stop use and ask a doctor if

Condition worsens, or if symptoms persist more than 7 days, or clear up and reoccur.

Keep out of reach of children

if swallowed, call your Poison Control Center at 1 (800) 222-1222.

Directions

  • adults and children 12 years of age and older: Apply liberally to the affected area(s) and continue to massage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 times daily or as needed.
  • children under 12 years of age, consult a doctor.

Other Information

  • store in room temperature (59~86°F)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice Extract, Arnica Montana Flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camphor, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract, Cholesterol, Dimethicone, Dimethyl Isosorbide Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil, Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Lecithin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Purified Water, Pyridoxine HCL (Vit. B6), SD Alcohol 40-B, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine

Lightning Pain Relief Cream, 2.28 fl.oz/ 65g (63742-013-00)

65

Lightning Pain Relief Cream, 3.56 fl.oz/101g (63742-013-01)

101

LIGHTNING PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
SHEA BUTTER (UNII: K49155WL9Y)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
EMU OIL (UNII: 344821WD61)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAURETH-7 (UNII: Z95S6G8201)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TEA TREE OIL (UNII: VIF565UC2G)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63742-013-0065 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
2NDC:63742-013-01101 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2019
Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 6/2022
Document Id: e26f6aa6-c978-2fec-e053-2995a90a328e
Set id: 80af21f5-dba8-42b0-8a65-ac5a94d83ca8
Version: 2
Effective Time: 20220627
 
Clinical Resolution Laboratory, Inc.