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:

• not intended for ingestion. For external use only

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 Poison Control Center right away. • Do not apply to wounds or damaged skin. • Do not bandage tightly.

If pregnant or breast feeding,

• contact a 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 CST)

Package Labeling:5ml

Label

Package Labeling:118ml

Label2

SCLERA CARE TOPICAL ANESTHETIC GEL
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73698-281
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73698-281-00	5 mL in 1 PACKET; Type 0: Not a Combination Product	03/21/2022
2	NDC:73698-281-01	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/21/2022

Labeler - ScleraCare, LLC (114220391)

SCLERA CARE Topical Anesthetic Gel