Cooling Acute Pain Relief
FDA Label NDC 57955-7302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Cooling Acute Pain Relief (NDC 57955-7302). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients

Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum.

Equal volumes of each active ingredient in 10X, 30X, and LM1 potencies. Active ingredients 50% of total weight.

Indications & Usage

Uses for temporary relief of symptoms: •back and neck pain •muscle and joint pain •muscle cramps and stiffness •inflamed muscles and joints •muscle tension and soreness •body aches •tired legs and feet •stiff and swollen joints

Warnings

Warnings

  • For external use only. Avoid contact with eyes and broken skin.
  • Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
  • Nursing mothers should not apply to breast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions

•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.

Other Safety Information

Other information:

  • To open: unscrew cap, remove tube seal, replace cap.
  • Safety sealed for your protection.
  • Do not use if tube seal is missing.
  • Store at 68-77° (20-25°C).

Inactive Ingredient

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, menthol, peppermint oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lacyltate, sweet almond oil, sweet birch oil.

Otc - Purpose

Uses: for temporary relief of symptoms:

  • back and neck pain
  • muscle and joint pain
  • muscle cramps and stiffness
  • inflamed muscles and joints
  • muscle tension and soreness
  • body aches
  • tired legs and feet
  • stiff and swollen joints

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