SCLERACARE LIDOCAINE HCL- lidocaine hydrochloride gel 
ScleraCare, LLC

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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ScleraCare Lidocaine HCL 3% Gel

Drug Facts

Active Ingredient:

Lidocaine hydrochloride 3.00%

Purpose

Topical Anesthetic

Uses:

• For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings:

• For external use only not intended for ingestion.

When using this product

• Avoid contact with eyes

Do not use 

• in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if

symptoms persist for more than seven days.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poinson Control Center right away.
• Do not apply to wounds or damaged skin.
• Do not bandage tightly.
• If pregnant or breast feeding, contact physician prior to use.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
• Children under two-years of age: consult a physician.

Inactive Ingredients:

a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Opuntia Vulgaris (Prickly Pear) Extract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Polysorbate-20, Sodium Alginate, Squalane, Triethanolamine.

Other Information:

• Store at room temperature

Question?

337-526-6744 (M-F) (9-5pm EST)

Package Labeling:

Label

SCLERACARE LIDOCAINE HCL 
lidocaine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73698-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CUCUMBER (UNII: YY7C30VXJT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SQUALANE (UNII: GW89575KF9)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73698-106-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/10/2020
Labeler - ScleraCare, LLC (114220391)

Revised: 3/2020
Document Id: a0a8cafa-8ea4-2f66-e053-2a95a90a52b5
Set id: 550df5b8-52cd-4bca-b19d-f40ce050e893
Version: 1
Effective Time: 20200312
 
ScleraCare, LLC