Label: TOUGH LOVE PAIN RELIEVING- lidocaine hcl cream
- NDC Code(s): 62742-4222-1, 62742-4222-2
- Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 28, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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OTHER SAFETY INFORMATION
Other safety information and warning
Warning: For adults only. Consult your physician before use if you are pregnant, lactating, taking medications, or have a medical condition. Keep out of reach of children.
Warning: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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INACTIVE INGREDIENT
Inactive Ingredient
Water ((Aqua), Glyceryl stearate, Butyrospermum Parkii Nut Extract, glycerin, Ceteraryl Alcohol, Broad Spectrum Hemp Extract, Cetearyl Olivate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Sorbitan Olivate, stearic Acid, Candelilla/Jojoba/Rice Bran Polyglyceride-3Esters, Linum Usitatissimum(Linseed) Seed Oil, Sodium Phytate,Xanthan Gum, Hydroxyapatite, Citric Acid,Tocopherol,
Persea Gratissima (Avocado) Oil,Sodium Stearoyl Lactylate,Viburnum Opulus Bark Extract, Alcohol,Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender)Oil,Cananga Odorata Flower Oil, Melia Azadirachta Flower Extract,Corallina Officinalis Extract,Cocconia Indica Fruit Extract,Melia Azadirachta Leaf extract,Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract,Ocimum Sanctum Leaf Extract,Curcuma Longa (Turmeric) Root Extract, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin, Hexylene Glycol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOUGH LOVE PAIN RELIEVING
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4222 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength RICE BRAN (UNII: R60QEP13IC) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) YLANG-YLANG OIL (UNII: 8YOY78GNNX) VIBURNUM OPULUS BARK (UNII: T1UG6H6805) CANDELILLA WAX (UNII: WL0328HX19) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) SORBITAN OLIVATE (UNII: MDL271E3GR) SHEANUT (UNII: 84H6HBP32L) LINSEED OIL (UNII: 84XB4DV00W) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETEARYL OLIVATE (UNII: 58B69Q84JO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) ALOE VERA FLOWER (UNII: 575DY8C1ER) TURMERIC (UNII: 856YO1Z64F) XANTHAN GUM (UNII: TTV12P4NEE) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) TOCOPHEROL (UNII: R0ZB2556P8) AVOCADO OIL (UNII: 6VNO72PFC1) LAVENDER OIL (UNII: ZBP1YXW0H8) EGGPLANT (UNII: W5K7RAS4VK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) JOJOBA OIL GLYCERETH-8 ESTERS (UNII: 435WC6V33R) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CORALLINA OFFICINALIS (UNII: 4004498D06) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) HOLY BASIL LEAF (UNII: SCJ765569P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALOE VERA LEAF (UNII: ZY81Z83H0X) CANNABIDIOL (UNII: 19GBJ60SN5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4222-2 1 in 1 CARTON 11/28/2022 1 NDC:62742-4222-1 50 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/28/2022 Labeler - Allure Labs Inc (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4222)