OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT
LIDOCAINE 4%
MENTHOL 1.25%
PAIN RELIEF
- Manufacturer
- Genuine Virgin Aloe Corporation
- Effective date
- 2019-05-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:23:31
Label at a glance#
ProductPAIN RELIEF
Active ingredientLIDOCAINE, MENTHOL
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
TOPICAL ANESTHETIC
INDICATIONS & USAGE SECTION
Temporarily relieves minor pain, itching and irritation due to/associated with:
- ARTHRITIS
- SIMPLE BACKACHE
- MUSCLE STRAINS
- SPRAINS
- BRUISES
- MINOR CUTS/SCRAPES
- MINOR BURNS/SUNBURN
- INSECT BITES
WARNINGS SECTION
FOR EXTERNAL USE ONLY
OTC - DO NOT USE SECTION
DO NOT USE
- IF YOU ARE ALLERGIC TO ANY TYPE OF NUMBING MEDICINE
- IN LARGE QUANTITIES, PARTICULARLY OVER RAW SURFACES OR BLISTERED AREAS
- ON INFECTIONS
- ON DEEP PUNCTURE WOUNDS
- ON RAW SURFACES OR BLISTERED AREAS
OTC - WHEN USING SECTION
WHEN USING THIS PRODUCT
- DO NOT USE OVER LARGE SKIN AREAS
- DO NOT APPLY HEAT, BANDAGES OR PLASTIC WRAP TO TREATED AREAS
- DO NOT USE IN OR NEAR THE EYES
- WASH HANDS IMMEDIATELY AFTER USING
OTC - STOP USE SECTION
STOP USE AND ASK A DOCTOR IF
- ALLERGIC REACTION OCCURS
- CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS
- SYMPTOMS CLEAR UP AND RETURN WITHIN A FEW DAYS
- REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN OR INCREASE.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
- APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 3 TO 4 TIMES A DAY. FOR USE ON ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER. CHILDREN UNDER 2 YEARS - ASK A DOCTOR.
INACTIVE INGREDIENT SECTION
Inactive ingredients: allantoin, aloe barbadensis (AP4® genuine virgin organic aloe vera) leaf extract, arnica montana flower extract, boswellia serrata gum, butyrospermum parkii (shea butter), calophyllum tacamahaca fruit (tamanu nut) oil, carbomer, cetearyl alcohol, chamomilla recutita matricaria (chamomile) extract, glyceryl stearate, hypericum perforatum (st. john’s wort), isopropyl palmitate, persea gratissima (avocado) oil, phenoxyethanol, polysorbate-60, sodium polyacrylate, squalane, stearyl alcohol, trideceth-6
OTC - PREGNANCY OR BREAST FEEDING SECTION
DO NOT USE
- IF PREGNANT OR BREAST FEEDING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LIDOCAINE | ACTIVE INGREDIENT | 98PI200987 | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| ARNICA MONTANA FLOWER WATER | INACTIVE INGREDIENT | U7L2JP51PR | 1 | |
| AVOCADO OIL | INACTIVE INGREDIENT | 6VNO72PFC1 | 1 | |
| BOSWELLIA SERRATA WHOLE | INACTIVE INGREDIENT | X7B7P649WQ | 1 | |
| CALOPHYLLUM TACAMAHACA WHOLE | INACTIVE INGREDIENT | 179EAP33MM | 1 | |
| CARBOMER 934 | INACTIVE INGREDIENT | Z135WT9208 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CHAMOMILE | INACTIVE INGREDIENT | FGL3685T2X | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| HYPERICUM PERFORATUM | INACTIVE INGREDIENT | XK4IUX8MNB | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 1 | |
| SODIUM POLYACRYLATE (8000 MW) | INACTIVE INGREDIENT | 285CYO341L | 1 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| TRIDECETH-6 | INACTIVE INGREDIENT | 3T5PCR2H0C | 1 |
Products#
Every source-derived product name is available through these pages.
- PAIN RELIEF
- LIDOCAINE AND MENTHOL
- LIDOCAINE
- MENTHOL
- ALOE VERA LEAF
- ALLANTOIN
- ARNICA MONTANA FLOWER WATER
- BOSWELLIA SERRATA WHOLE
- SHEA BUTTER
- CALOPHYLLUM TACAMAHACA WHOLE
- CARBOMER 934
- CETOSTEARYL ALCOHOL
- CHAMOMILE
- HYPERICUM PERFORATUM
- GLYCERIN
- GLYCERYL MONOSTEARATE
- ISOPROPYL PALMITATE
- AVOCADO OIL
- PHENOXYETHANOL
- SODIUM POLYACRYLATE (8000 MW)
- TRIDECETH-6
- POLYSORBATE 60
- SQUALANE
- STEARYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10738-201 | 10738-201-12, 10738-201-54 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / ORAL | 33.34 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | EMULSION / ORAL | 20 mg/1ml | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | SUSPENSION/ DROPS / OPHTHALMIC | 0.4 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | SUSPENSION / OPHTHALMIC | 0.45 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | POWDER / ORAL | 0.11 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / ORAL | 125 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL / TOPICAL | 397 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, CHEWABLE / ORAL | 1 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SUPPOSITORY / VAGINAL | NA | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / TOPICAL | 2.85 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| CARBOMER 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CREAM / TOPICAL | 600 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | FILM, EXTENDED RELEASE / TRANSDERMAL | 187.5 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE, EXTENDED RELEASE / ORAL | 32.4 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | GEL / TOPICAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | GUM, CHEWING / BUCCAL | 5 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| SQUALANE | SQUALANE | GW89575KF9 | SOLUTION / TOPICAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b8a448d9-ac71-e2d7-e053-2a95a90a1405 | c88e971f-7c26-44be-ba28-71ea43718d44 | 2021-01-11 | Warnings | c88e971f-7c26-44be-ba28-71ea43718d44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.