TOUGH LOVE PAIN RELIEVING- lidocaine hcl cream 
Allure Labs Inc

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.

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Drug Facts

Active Ingredients

Lidocaine HCL 4 %

Purpose

Pain Reliver

Uses

Temporarily relieves minor pain associated with Muscle strains,sprain and simple backache,insect bites.

Warnings

For external use only

Do not uses

Do not apply to wounds or damaged skin

When using this Product use only as directed

do not bandage tightly or use with a heating pad

Stop uses

Condition Worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Redness is present

Irritation develops

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away

Direction

Adults and children over 12 years of age

apply externally to affected area up to 2-3 time a day.

repeat as necessary, but no more than 4 time daily.

children 12 year or younger ask a doctor

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.

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

Toughlovepainrelieving

TOUGH LOVE PAIN RELIEVING 
lidocaine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4222-21 in 1 CARTON11/28/2022
1NDC:62742-4222-150 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/28/2022
Labeler - Allure Labs Inc (926831603)
Registrant - Allure Labs Inc (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs Inc926831603manufacture(62742-4222)

Revised: 11/2022
Document Id: ee8c1a2b-36f0-6fd7-e053-2a95a90a9c01
Set id: ee8c1a2b-36ef-6fd7-e053-2a95a90a9c01
Version: 1
Effective Time: 20221128
 
Allure Labs Inc