Vicks Vapofreeze Cream
FDA Label NDC 84126-302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Vapofreeze (NDC 84126-302). 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 other, active ingredients, active ingredients purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredients

→ Active Ingredients Purpose

→ Use

→ Warnings

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Otc - Keep Out Of Reach Of Children

→ If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

→ Directions

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 3 Oz

Other

Drug Facts

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

Active Ingredients

Camphor 3.6%

Menthol 16%

Active Ingredients Purpose

Topical anesthetic

Topical analgesic

Use

temporarily relieves minor pain aches and pains of muscles and joints associated with:

arthritis
simple backache
strains
sprains
bruises

provides penetrating pain relief

Warnings

For external use only

Do Not Use

on wounds or on irritated or damaged skin
with a heating pad

When Using This Product

use only as directed.
do not bandage tightly or use with medicated patch
avoid contact with eyes and mucous membranes
do not expose the area to local heat or direct sunlight
a transient burning sensation may occur upon application but generally disappears in several days
avoid applying into skin folds

Stop Use And Ask A Doctor If

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
redness is present or excessive skin irritation occurs
you experience severe burning pain, swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If Swallowed, Get Medical Help Or Contact A Poison Control Center Right Away.

Directions

adults and children over 12 years of age and older:

apply to the affected area not more than 3 to 4 times daily
wash hands thoroughly with soap and water after each use

children under 12 years of age:ask a doctor

Store at no greater than 25°C (77°F).

Inactive Ingredients

carbomer homopolymer, cetyl alcohol, cetyl palmitate, edetate disodium, fragrance, glycerin, isopropyl isostearate, PEG-100 stearate, sodium hydroxide, stearic acid, stearyl alcohol, water