Pain Relieving Lotion
FDA Label NDC 68678-039

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ahc Ventures Corp Dba Cry for the product Pain Relieving (NDC 68678-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding directions, active ingredient, inactive ingredients, other information, keep out of reach of children, purpose, uses, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Directions

Adults and children 2 years and older:
Massage a small amount of lotion directly on the skin over the affected area. Repeat as necessary but do not apply more than 4 times daily.
Children under 2 years of age: Consult a Physician

Active Ingredient

Menthol USP 3.85%
Camphor USP 3.85%
Capsaicin USP 0.0355%

Inactive Ingredients

Aloe Vera, Arnica Extract, Boswellia Serrata Extract, Green Tea Extract, Carbomer, Cetearyl Alcohol, Cetearyl Glucoside, Orange Fruit Extract, Grapefruit Extract, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis Leaf Extract, Phenoxyethanol, Purified Water, Rose Extract, Vitamin E, Triethanolamine, Yucca Extract

Other Information

Store in a cool dry place with lid or cap closed tightly.
Flammable: Keep away from excessive heat or open flame

Keep Out Of Reach Of Children

In case of accidental ingestion get medical help or contact a Poison Control Center immediately

Purpose

Pain Reliever

Uses

Temporary relieves minor aches and pains associated with

  • sore muscles and joints
  • arthritis
  • backache
  • muscle strains
  • sprains
  • bruises

Warnings

For external use only

When Using This Product:

Use only as directed. Do not bandage or use a heating pad or device. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use with other ointment, creams, sprays or liniments. After applying wash hands thoroughly with cool water

Stop Use And Ask A Doctor If:

Condition worsens or symptoms persist for more than 7 days or clear up and recur. Redness is present or irritatio develops

If Pregnant Or Breast Feeding:

Ask a health professional before use

This Product Contains Capsaicin

and may cause temporary burning, stinging, inflammation, redness or welts on the application site thatususally disappear in a few days. If you experience any of these symptoms discontinue use and contact your doctor immediately

* Please review the disclaimer below.