sclera care topical anesthetic gel

sclera care topical anesthetic gel
SPL v2
SPL
SPL Set ID 488ace02-fc0b-4d13-ab89-0e1640e915e5
Route
topical
Published
Effective Date 2022-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
allantoin aloe vera leaf water butylene glycol cucumber ethylhexylglycerin avocado oil phenoxyethanol polysorbate 20 sodium alginate squalane trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-03-21

Purpose

Topical Anesthetic

Description

Lidocaine hydrochloride 3.00%


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine hydrochloride 3.00%

Uses:

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

Question?

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

Warnings:

• not intended for ingestion. For external use only

Do Not Use

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

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.

Active Ingredient:

Lidocaine hydrochloride 3.00%

Other Information:

• Store at room temperature

Package Labeling:5ml

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.

Package Labeling:118ml

When Using This Product

• Avoid contact with eyes

Stop Use and Ask A Doctor If

symptoms persist for more than seven days.

If Pregnant Or Breast Feeding,

• contact a physician prior to use.

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.




Structured Label Content

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.

Question?

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

Warnings:

• not intended for ingestion. For external use only

Do Not Use (Do not use)

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

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.

Active Ingredient:

Lidocaine hydrochloride 3.00%

Other Information:

• Store at room temperature

Package Labeling:5ml

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.

Package Labeling:118ml

When Using This Product (When using this product)

• Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist for more than seven days.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

• contact a physician prior to use.

Keep Out of Reach of Children. (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.




Advanced Ingredient Data


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