PR- menthol lotion 
Amphp, Inc

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Menthol 0.5%

Pain relieving sports lotion

For the temporary relief of pain

For external use only

Do not use if allergic to any ingredient in this product or sensitive to sodium

Use only as directed. Avoid contact with eyes.

Stop use and ask doctor if:

Symptoms persist for more than 7 days

Symptoms 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.

Shake well. 15 minutes to 2 hours before your workout, apply generously to the muscles you use most (30 minutes before water sports). Completely cover each muscle, a palmful per use. Reapply after for added recovery. Wash hands.

Adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: consult a doctor

Store at 20-25C (68-77F)

sodium bicarbonate, water, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, polygylceryl-4 laurate, hydrated silica, cocos nucifera (coconut) oil, simmondsia chinensis (jojoba) seed oil, caprylic/capric triglyceride, sodium hydroxide, fragrance

PR Lotion 300 gram tube principal display panel

Standard Tube

PR Lotion 20 gram packet principal display panel

On-The-Go Packet

PR Lotion 100 gram tube principal display panel

Travel Tube

PR 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72358-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72358-101-04300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2018
2NDC:72358-101-0320 g in 1 PACKET; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/2018
Labeler - Amphp, Inc (081138140)

Revised: 12/2023
Document Id: 0bb43095-e397-3c27-e063-6294a90a4089
Set id: 6f5b9e08-c445-4fac-e053-2a91aa0aa737
Version: 7
Effective Time: 20231204
 
Amphp, Inc