Painzaway Pain Relieving Gel

Painzaway Pain Relieving Gel
SPL v2
SPL
SPL Set ID dba1d268-ebab-0ac7-e053-2a95a90ad4b6
Route
TOPICAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.6 g)
Inactive Ingredients
Propylene Glycol Trolamine Aloe Vera Leaf Alcohol Glucosamine Sulfate Tea Leaf Oil Imidurea Water Carbomer 940 Dimethyl Sulfone Fd&c Blue No. 1 Emu Oil Glycerin

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-19

Description

Menthol 4.6%

Purpose

topical analgesic


Medication Information

Purpose

topical analgesic

Description

Menthol 4.6%

Uses

■ Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains. ■ Provides cooling pain relief.

Section 42229-5

MANUFACTURED BY

INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE., HOBART, IN 46342

Website: BotanicChoice.com

Section 51945-4

PainzAway®

PAIN RELIEVING GEL

NET WT. 5 OZ.

Warnings

For external use only

Directions

See the important warnings under "when using this product"

■ 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: Consult a physician.

Questions?

1-800-644-8327

Active Ingredient

Menthol 4.6%

Other Information:

Use only if seal is unbroken.

Inactive Ingredients

Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD Alcohol 39B, Triethanolamine, Water

When Using This Product

■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot water or any container when heating water. May cause splattering and result in burns. ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

■ Temporary relief of minor aches and pains of muscles & joints associated with simple backache, arthritis, bruises and sprains. ■ Provides cooling pain relief.

Section 42229-5 (42229-5)

MANUFACTURED BY

INDIANA BOTANIC GARDENS, INC.

3401 W. 37TH AVE., HOBART, IN 46342

Website: BotanicChoice.com

Section 51945-4 (51945-4)

PainzAway®

PAIN RELIEVING GEL

NET WT. 5 OZ.

Purpose

topical analgesic

Warnings

For external use only

Directions

See the important warnings under "when using this product"

■ 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: Consult a physician.

Questions?

1-800-644-8327

Active Ingredient

Menthol 4.6%

Other Information:

Use only if seal is unbroken.

Inactive Ingredients

Aloe Vera Concentrate, Carbomer 940, Emu Oil, FD&C Blue #1, Glucosamine Sulfate, Glycerin, Green Tea Fragrance, Imidazolidinyl Urea, MSM Powder, Propylene Glycol, SD Alcohol 39B, Triethanolamine, Water

When Using This Product (When using this product)

■ Do not heat ■ Do not microwave ■ Do not use near open flame ■ Do not add to hot water or any container when heating water. May cause splattering and result in burns. ■ Avoid contact with eyes ■ Do not apply to wounds or damaged skin ■ Do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

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.


Advanced Ingredient Data


Raw Label Data

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