dg health cold zone pain relieving gel

dg health cold zone pain relieving gel
SPL v4
SPL
SPL Set ID 22594ab8-9a4a-426f-aced-5c636620fa2c
Route
topical
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (40 mg)
Inactive Ingredients
aloe vera leaf arnica montana flower fd&c blue no. 1 indian frankincense calendula officinalis flower green tea leaf camphor (synthetic) carbomer homopolymer, unspecified type glycerin isopropyl alcohol isopropyl myristate sodium hydroxide .alpha.-tocopherol acetate, dl- water fd&c yellow no. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2020-03-05

Purpose

Topical analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Purpose

Topical analgesic

Directions

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Inactive Ingredients

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrtata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9

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

Section 53414-9

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

Active Ingredient

Menthol 4%

Questions Or Comments?

1-888-309-9030

When Using This Product
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices
Principal Display Panel 59 Ml Tube Label

DG™|health

Compare to

active

ingredient

of BIOFREEZE®

GEL*

Cold Zone

Pain Relieving

Gel

Topical Relief

Menthol 4% Topical Analgesic

  • For arthritis, backache,

    muscle pain and joint pain
  • Soothing Menthol
  • Paraben free

2 FL OZ (59 mL)


Structured Label Content

Warnings

For external use only

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Purpose

Topical analgesic

Directions

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrtata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 50566-9 (50566-9)

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

Section 53414-9 (53414-9)

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

Active Ingredient (Active ingredient)

Menthol 4%

Questions Or Comments? (Questions or comments?)

1-888-309-9030

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices
Principal Display Panel 59 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 59 mL Tube Label)

DG™|health

Compare to

active

ingredient

of BIOFREEZE®

GEL*

Cold Zone

Pain Relieving

Gel

Topical Relief

Menthol 4% Topical Analgesic

  • For arthritis, backache,

    muscle pain and joint pain
  • Soothing Menthol
  • Paraben free

2 FL OZ (59 mL)


Advanced Ingredient Data


Raw Label Data

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