Globe Pain Relieving Cream+ Lidocaine

Globe Pain Relieving Cream+ Lidocaine
SPL v3
SPL
SPL Set ID 039a2036-54b2-cf28-e063-6294a90a8ce6
Route
TOPICAL
Published
Effective Date 2023-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzyl Alcohol (4 g)
Inactive Ingredients
Dihexadecyl Phosphate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Water Cetostearyl Alcohol Aloe Vera Leaf Maltodextrin Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Butylene Glycol Ceteth-10 Phosphate Steareth-21 Aminomethylpropanol Dimethicone Glyceryl 1-stearate Polysorbate 80 Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-23
Description

Lidocaine HCL 4%

Purpose

Topical Anasthetic

Medication Information

Purpose

Topical Anasthetic

Description

Lidocaine HCL 4%

Uses

Temporary Pain Relief

Section 51945-4

Section 55106-9

Benzyl Alcohol 10%

Warnings

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Questions

Call 1-888-296-9067

Directions

Adults and children over 12 years

  • clean and dry affected area
  • Apply to affected area not more than 3 to 4 times daily

Children 12 years or younger

  • ask a doctor
Do Not Use
  • On wounds or damaged skin
  • In large quantities
  • With a heating pad
  • if you are allergic to any ingredients of this product
Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Lidocaine HCL 4%

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients

Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

When Using This Product
  • Use only as direcgted
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor If
  • Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
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 (800-222-1222) right away

Structured Label Content

Uses

Temporary Pain Relief

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Benzyl Alcohol 10%

Purpose

Topical Anasthetic

Warnings

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Questions

Call 1-888-296-9067

Directions

Adults and children over 12 years

  • clean and dry affected area
  • Apply to affected area not more than 3 to 4 times daily

Children 12 years or younger

  • ask a doctor
Do Not Use
  • On wounds or damaged skin
  • In large quantities
  • With a heating pad
  • if you are allergic to any ingredients of this product
Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Active Ingredient

Lidocaine HCL 4%

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients

Aloe barbadensis leaf juice, aminomethyl propanol, Butylene glycol, carbome interpolymer type A (allyl sucrose crosslinked), Ceteth-10 phosphate, Cetostearyl alcohol, Dihexadecyl phosphate, Dimethicone, Glyceryl 1-stearate, Hydroxyethly acrylate/sodium acryloydimethyl taurate copolymer, maltodextrin, polysorbate 80, SD alcohol, Steareth-21, water

When Using This Product (When Using this Product)
  • Use only as direcgted
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor If)
  • Skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
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 (800-222-1222) right away

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:07.597842 · Updated: 2026-03-14T23:06:27.679265