Globe Maximum Strength Pain & Itch Relief Cream

Globe Maximum Strength Pain & Itch Relief Cream
SPL v2
SPL
SPL Set ID f40b19a8-795c-f514-e053-2a95a90a6d15
Route
TOPICAL
Published
Effective Date 2023-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Steareth-21 Phenoxyethanol Water Cyclomethicone 7 Edetate Disodium Anhydrous Glyceryl Monostearate Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Maltodextrin Isohexadecane Aminomethylpropanol Cetostearyl Alcohol Ceteth-10 Phosphate Dihexadecyl Phosphate Dimethicone Ethylhexylglycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Alcohol Aloe Vera Leaf Carbomer Interpolymer Type A (55000 Cps)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-06

Description

Lidocaine HCI 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine HCI 4%

Uses

Temporarily relieves minor pain

Warnings

For external use only.

Packaging

Questions

For Questions please call 1 888 296 9067

Directions

Adults and children over 12 years:

Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.

Children 12 years or younger: ask a doctor

Do Not Use

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.

Active Ingredient

Lidocaine HCI 4%

Other Information

Store at room temperature

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

When Using This Product

Use only as directed.

Do not allow contact with eyes.

Do not bandage or apply local heat such as heating pads to the area of use

If Pregnant Or Breast Feeding

Ask a health professional before use.

Keep Out of Reach of Children

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

Stop Use and Ask A Doctor If:
  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Structured Label Content

Uses

Temporarily relieves minor pain

Purpose

Topical Anesthetic

Warnings

For external use only.

Packaging

Questions

For Questions please call 1 888 296 9067

Directions

Adults and children over 12 years:

Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.

Children 12 years or younger: ask a doctor

Do Not Use

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

Distributed By

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.

Active Ingredient

Lidocaine HCI 4%

Other Information

Store at room temperature

Inactive Ingredient:

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

When Using This Product (When using this product)

Use only as directed.

Do not allow contact with eyes.

Do not bandage or apply local heat such as heating pads to the area of use

If Pregnant Or Breast Feeding (If Pregnant or Breast Feeding)

Ask a health professional before use.

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

Stop Use and Ask A Doctor If: (Stop Use and ask a Doctor if:)
  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Advanced Ingredient Data


Raw Label Data

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