OTC Medication Information: Topical Edge

TOPICAL EDGE- menthol lotion
AmperSand Biopharma

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.

Topical Edge Label
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TOPICAL EDGE
menthol lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70458-500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
JOJOBA OIL
SORBIC ACID
POLYGLYCERYL-4 OLEATE
POLYGLYCERYL-4 STEARATE
WATER
ISOPROPYL PALMITATE
COCONUT OIL
PALM KERNEL OIL
SODIUM BICARBONATE
ALCOHOL
BENZYL ALCOHOL
HYDRATED SILICA
LECITHIN, SOYBEAN
POLOXAMER 407
MEDIUM-CHAIN TRIGLYCERIDES
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70458-500-02 300 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/25/2017
Labeler — AmperSand Biopharma (080111681)

Revised: 08/2017 AmperSand Biopharma

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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