Cool Breeze
FDA Label NDC 72744-778

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cool Breeze Us Llc for the product Cool Breeze (NDC 72744-778). 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 drug facts, active ingredients, purpose, use, warning, otc - keep out of reach of children, directions, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthol  5.0%
Methyl Salicylate  4.0%

Purpose

External analgesic

Use

temporarily relieves minor pain associated with:
• Arthritis | Backache | Muscles | Strains | Sprains | Bruises | Cramps

Warning

• Flammable keep away from fire or flame
• For external use only
• Store in cool dry place

When using this product - use only as directed
• Do not bandage tightly or use with a heating pad
• Avoid contact with eyes and mucus membranes
• Do not apply to wounds or damaged, broken or irritated skin
• A burning sensation may occur upon application but generally disappears

If gel comes in contact with eyes, wash with warm water

Stop use and ask a doctor if
• Condition worsens
• Symptoms persists for more than 7 days or pain continues to occur

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children, In case of accidental ingestion, Get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

• Apply generously to affected area.
• Massage into painful area until thoroughly absorbed into skin
• Repeat as necessary, But no more than 4 times daily

Children 12 years or younger:
• Please speak with a doctor

Inactive Ingredients:

A non-alkaline base with water and color.

Packaging

Cool Breeze-778 (7274477840 2)

Cool Breeze-778 (7274477840 2)

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