Skip to Content

← See all Topical Edge brands

Topical Edge by AmperSand Biopharma

Medically reviewed on March 4, 2017

Dosage form: lotion
Ingredients: MENTHOL 0.5g in 100g
Labeler: AmperSand Biopharma
NDC Code: 70458-500

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.

Active Ingredient          Purpose

Menthol 0.5%                    Pain relieving sports lotion

Uses: For the temporary relief of pain.

For external use only

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

When using this product 

Stop use and as a doctor if  symptoms persist for more than 7 days symptoms clear up and occur again within a few days

If Pregnant or breastfeeding, 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.

knead packets before use

apply generously to target muscle groups at least 15 minutes prior to activity, or post-activity for recovery

use 2 packets per lower body workout (1 on each leg) or 1 packet per upper body workout

wash hands.

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

Children under 2 years of age
apply to affected area not more than 3 to 4 times daily consult a doctor

use 2 packets per lower body workout (1 on each leg) or 1 packet per upper body workout

store at 20-25°C (68-77°F)

Sodium bicarbonate, water/aqua, isopropyl palmitate, lecithin, poloxamer 407, alcohol denat., benzyl alcohol, cocos nucifera oil, simmondsia chinensis seed oil, caprylic/capric triglyceride, lippia citriodora flower extract, sorbic acid, sodium hydroxide.

TOPICAL EDGE 
menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70458-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE 
WATER 
ISOPROPYL PALMITATE 
LECITHIN, SOYBEAN 
POLOXAMER 407 
ALCOHOL 
BENZYL ALCOHOL 
COCOS NUCIFERA WHOLE 
SIMMONDSIA CHINENSIS SEED 
LIPPIA CITRODORA FLOWER 
SORBIC ACID 
sodium hydroxide 
Packaging
#Item CodePackage Description
1NDC:70458-500-0110 PACKET in 1 CARTON
110 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/201703/04/2019
Labeler - AmperSand Biopharma (080111681)
Registrant - AmperSand Biopharma (080111681)
Establishment
NameAddressID/FEIOperations
AmperSand Biopharma080111681label(70458-500)

 
AmperSand Biopharma

← See all Topical Edge brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide