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

Purpose

Topical Anasthetic

Description

Lidocaine HCL 4%

Medication Information

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

Active Ingredient

Benzyl Alcohol 10%

Uses

Temporary Pain Relief

Purpose

Topical Anasthetic

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

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

Description

Lidocaine HCL 4%

Section 51945-4

Questions

Call 1-888-296-9067

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%

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

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

Active Ingredient (55106-9)

Benzyl Alcohol 10%

Uses

Temporary Pain Relief

Purpose

Topical Anasthetic

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

Other Information

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

Inactive Ingredients

Section 51945-4 (51945-4)

Questions

Call 1-888-296-9067

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%

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

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporary Pain Relief", "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": "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"}

Additional Information

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