Crl (as Cmo) Kool N Fit Inc. - Pain Reliever (84733-302)

SPL v3

SPL

SPL Set ID 2253f6bd-5707-b993-e063-6394a90aa74a

Route

TOPICAL

Published

Effective Date 2024-10-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Camphor (synthetic) (0.2 g) Menthol (1.25 g)

Inactive Ingredients

Water Bergamot Oil Polysorbate 20 Peppermint Oil Tert-butyl Alcohol Nutmeg Oil Pine Needle Oil (pinus Mugo) Thyme Oil Lemon Oil Rosemary Oil Eucalyptus Oil Juniper Berry Oil Lavender Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-10-11

Description

Store in a cool dry place

Purpose

for the temporary relief of minor aches and pains of muscle and joints asscoiated with simple backache, strains, brusies and sprains.

Medication Information

Purpose

for the temporary relief of minor aches and pains of muscle and joints asscoiated with simple backache, strains, brusies and sprains.

Description

Store in a cool dry place

Use

USE ONLY AS DIRECTED.

Section 50565-1

KEEP OUT OF REACH CHILDREN - IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Warning

FOR EXTERNAL USE ONLY.

Direction

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:

APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.

CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE, CONSULT DOCTOR.

Other Info

Store in a cool dry place

Product Label

KOOL N FIT - PAIN RELIEVING SPRAY

Active Ingredient

Camphor 0.20%

Menthol 1.25%

Inactive Ingredient

ALCOHOL SDA-40, AQUA DEIONIZED, USP, BERGAMOT OIL, CITRUS OIL, EUCALYPTUS OIL, JUNIPERBERRY OIL, PINE NEEDLE OIL, MYRISTICA OIL, LAVENDULA OIL, LEMON OIL, PEPPERMINT OIL, ROSEMARY OIL, THYME OIL

Recent Major Changes Section

COMPLETE ALL CONTENT SECTIONS TO ALIGN WITH PRODUCT PACKAGING

Structured Label Content

Use (USE)

USE ONLY AS DIRECTED.

Section 50565-1 (50565-1)

KEEP OUT OF REACH CHILDREN - IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Purpose (PURPOSE)

for the temporary relief of minor aches and pains of muscle and joints asscoiated with simple backache, strains, brusies and sprains.

Warning (WARNING)

FOR EXTERNAL USE ONLY.

Direction (DIRECTION)

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER:

APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.

CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE, CONSULT DOCTOR.

Other Info (OTHER INFO)

Store in a cool dry place

Product Label (PRODUCT LABEL)

KOOL N FIT - PAIN RELIEVING SPRAY

Active Ingredient (ACTIVE INGREDIENT)

Camphor 0.20%

Menthol 1.25%

Inactive Ingredient (INACTIVE INGREDIENT)

ALCOHOL SDA-40, AQUA DEIONIZED, USP, BERGAMOT OIL, CITRUS OIL, EUCALYPTUS OIL, JUNIPERBERRY OIL, PINE NEEDLE OIL, MYRISTICA OIL, LAVENDULA OIL, LEMON OIL, PEPPERMINT OIL, ROSEMARY OIL, THYME OIL

Recent Major Changes Section (RECENT MAJOR CHANGES SECTION)

COMPLETE ALL CONTENT SECTIONS TO ALIGN WITH PRODUCT PACKAGING

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USE": "USE ONLY AS DIRECTED.", "50565-1": "KEEP OUT OF REACH CHILDREN - IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.", "PURPOSE": "for the temporary relief of minor aches and pains of muscle and joints asscoiated with simple backache, strains, brusies and sprains.", "WARNING": "FOR EXTERNAL USE ONLY.", "DIRECTION": "ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE, CONSULT DOCTOR.", "OTHER INFO": "Store in a cool dry place", "PRODUCT LABEL": "KOOL N FIT - PAIN RELIEVING SPRAY", "ACTIVE INGREDIENT": "Camphor 0.20% Menthol 1.25%", "INACTIVE INGREDIENT": "ALCOHOL SDA-40, AQUA DEIONIZED, USP, BERGAMOT OIL, CITRUS OIL, EUCALYPTUS OIL, JUNIPERBERRY OIL, PINE NEEDLE OIL, MYRISTICA OIL, LAVENDULA OIL, LEMON OIL, PEPPERMINT OIL, ROSEMARY OIL, THYME OIL", "RECENT MAJOR CHANGES SECTION": "COMPLETE ALL CONTENT SECTIONS TO ALIGN WITH PRODUCT PACKAGING"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:12.487520 · Updated: 2026-03-14T23:10:26.709421