Pain Relieving Roll-on Lotion
FDA Label NDC 68678-040

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 Roll-on (NDC 68678-040). 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 warnings:, purpose, other information, active ingredient, directions, keep out of reach of children, inactive ingredients, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings:

For external use only

Purpose

Pain Reliever

Other Information

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

Active Ingredient

Menthol USP 3.85%

Camphor USP 3.85%

Capsaicin USP 0.0355%

Directions

Adults and children 2 years and older:
Apply a small amount directly on the skin over the affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more than 4 times daily.
Children under 2 years of age: Consult a Physician

Keep Out Of Reach Of Children

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

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

Uses

Temporary relieves minor aches and pains associated with

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

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

Pdp

CryoDerm

HEAT
PAIN RELIEVING
WARMING ROLL-ON

with
Menthol . Camphor . Capsaicin
And Essential Oils & Natural Extracts

Paraben Free / Propylene Glycol Free / Aspirin Free
NSAID Free / Silicone Dioxide Free / Gluten Free

Fast, Deep Penetrating Pain Relief for:
Muscle Strains, Joint Pain, Backache, Arthritis,
Sprained Ligaments & Bruises

Pain Relieving Lotion . Greaseless . No-Mess . Non-Staining

3 fl.oz. 84mL

* Please review the disclaimer below.