Ease Your Pain: Package Insert and Label Information

EASE YOUR PAIN- menthol cream
Proximity Capital Partners LLC dba Asutra

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.

Menthol USP 4%

Menthol USP 4% ……………………… Topical Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Use only as directed.

For external use only. Keep away from excessive heat or flame.

When using this product:

  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not bandage or use with a heating pad, other ointments, creams, sprays, or liniments

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breastfeeding: Ask a health professional before using.

Keep out of reach of children. If accidentally ingested, get medical help or contact Poison Control Center immediately.

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:

  • Consult physician.
  • Store in a cool, dry place.
  • Avoid direct sunlight.
  • Tamper-evident for your protection. Use only if safety seal is intact.
  • Keep away from excessive heat or flame.

Purified Water, Ethyl Alcohol, Dimethyl Sulfone (MSM), Arnica Montana, Calendula Officinalis Flower Extract, Methyl Glucose Dioleate, Sodium Hydroxide, Baobab Oil, Carbomer, Citric Acid

888-819-6472

Monday — Friday, 9am — 5pm CT

Report any serious side effects to number above.

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EASE YOUR PAIN
menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72683-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ADANSONIA DIGITATA SEED OIL
ARNICA MONTANA
CALENDULA OFFICINALIS FLOWER
CARBOXYPOLYMETHYLENE
CITRIC ACID MONOHYDRATE
DIMETHYL SULFONE
ALCOHOL
METHYL GLUCOSE DIOLEATE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72683-002-01 1 TUBE in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (72683-002-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/21/2019
Labeler — Proximity Capital Partners LLC dba Asutra (081214985)
Establishment
Name Address ID/FEI Operations
BioLyte Laboratories, LLC 015560564 manufacture (72683-002)

Revised: 12/2020 Proximity Capital Partners LLC dba Asutra

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