Care One 747.002/747ac

SPL v8

SPL

SPL Set ID 073c72fe-3171-4a4f-913a-d1b9630a1af3

Route

TOPICAL

Published

Effective Date 2025-08-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (7 mg)

Inactive Ingredients

Water Alcohol Polysorbate 20 Glycerin Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Sulisobenzone Sodium Hydroxide Benzyl Alcohol Phenoxyethanol Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-24

Description

Lidocaine HCl 0.7% Menthol 0.2%

Purpose

Topical analgesic

Adverse Reactions

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. DSP-TN-21091 DSP-MO-20087

Medication Information

Purpose

Topical analgesic

Adverse Reactions

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. DSP-TN-21091 DSP-MO-20087

Description

Lidocaine HCl 0.7% Menthol 0.2%

Uses

for the temporary relief of pain and itching associated with

minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritations

Warnings

For external use only

Directions

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: ask a doctor

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient

Lidocaine HCl 0.7%

Menthol 0.2%

Inactive Ingredients

water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, sodium hydroxide, benzyl alcohol, phenoxyethanol, blue 1

When Using This Product

avoid contact with the eyes

Principal Display Panel

CAREONE ^®

AFTER SUN

Gel with Aloe

Pain Relieving Gel

With Lidocaine and Menthol
Soothing
Moisturizing

NET 16 FL OZ (1 PT) 473 mL

Adverse Reactions Section

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

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

for the temporary relief of pain and itching associated with

minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritations

Purpose

Topical analgesic

Warnings

For external use only

Directions

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: ask a doctor

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient (Active ingredient)

Lidocaine HCl 0.7%

Menthol 0.2%

Inactive Ingredients (Inactive ingredients)

water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, sodium hydroxide, benzyl alcohol, phenoxyethanol, blue 1

When Using This Product (When using this product)

avoid contact with the eyes

Principal Display Panel (principal display panel)

CAREONE ^®

AFTER SUN

Gel with Aloe

Pain Relieving Gel

With Lidocaine and Menthol
Soothing
Moisturizing

NET 16 FL OZ (1 PT) 473 mL

Adverse Reactions Section (ADVERSE REACTIONS SECTION)

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE HYDROCHLORIDE ANHYDROUS", "unii": "EC2CNF7XFP", "classCode": "ACTIR", "strengthNumerator": "7", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of pain and itching associated with minor burns sunburn minor cuts scrapes insect bites minor skin irritations", "Purpose": "Topical analgesic", "Warnings": "For external use only", "Directions": "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: ask a doctor", "Do not use": "in large quantities, particularly over raw surfaces or blistered areas", "Active ingredient": "Lidocaine HCl 0.7% Menthol 0.2%", "Inactive ingredients": "water, alcohol denat., polysorbate 20, glycerin, Aloe barbadensis leaf juice, carbomer, benzophenone-4, sodium hydroxide, benzyl alcohol, phenoxyethanol, blue 1", "When using this product": "avoid contact with the eyes", "principal display panel": "CAREONE ® AFTER SUN Gel with Aloe Pain Relieving Gel With Lidocaine and Menthol Soothing Moisturizing NET 16 FL OZ (1 PT) 473 mL", "ADVERSE REACTIONS SECTION": "DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 For product questions or concerns, contact us at 1-833-992-3872 Quality guaranteed or your money back. DSP-TN-21091 DSP-MO-20087", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:33.635765 · Updated: 2026-03-14T23:12:49.502411