Totally Fun After Sun

Totally Fun After Sun
SPL v4
SPL
SPL Set ID 965a2a29-914c-4ad0-b25f-5df3c30da393
Route
TOPICAL
Published
Effective Date 2023-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Water Carboxypolymethylene Ethylhexylglycerin Poly(methyl Methacrylate; 450000 Mw) Fd&c Yellow No. 5 D&c Red No. 7 Phenoxyethanol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Lidocaine HCL 1.50%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine HCL 1.50%

Warnings

FOR EXTERNAL USE ONLY

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.
Do Not Use
  • in large quantites, particularly over raw or blistered areas.
  • Avoid contact with eyes.
Drug Facts

Indications

For the Temporary relief of pain and itching due to sunburn, minor skin irritations, minor cuts, minor burns, scrapes and insect bites.

Package Labeling

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethan-33, FD&C Yellow #5, D&C Red #7; Parfum (Orange Fragrance), Phenoxyethanol, Terephthalate, Triethanolamine. Glitter

Active Ingredients

Lidocaine HCL 1.50%

Additional Information

Store at room temperature.

Questions Or Comments?

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street,  Miami, FL 33172

www.sunshineglitter.com

All Rights Reserved.

Stop Use and Ask A Doctor
  • if condition gets worse, symptoms last for more than 7 days, or symptoms clear up and occur again with a few days.
  • If sumptoms persist for more than seven days, discontinue use and consult physician.
Keep Out of Reach of Children.

If swallowed, consult physician.


Structured Label Content

Purpose (PURPOSE)

Topical Anesthetic

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

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.
Do Not Use (Do not use)
  • in large quantites, particularly over raw or blistered areas.
  • Avoid contact with eyes.
Drug Facts

Indications

For the Temporary relief of pain and itching due to sunburn, minor skin irritations, minor cuts, minor burns, scrapes and insect bites.

Package Labeling

Other Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethan-33, FD&C Yellow #5, D&C Red #7; Parfum (Orange Fragrance), Phenoxyethanol, Terephthalate, Triethanolamine. Glitter

Active Ingredients

Lidocaine HCL 1.50%

Additional Information (Additional information)

Store at room temperature.

Questions Or Comments? (Questions or comments?)

Contact us directly at 1-888-601-0441

Distr. by/par: Sunshine & Glitter

MJ Products Association LLC

9750 NW 17th Street,  Miami, FL 33172

www.sunshineglitter.com

All Rights Reserved.

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if condition gets worse, symptoms last for more than 7 days, or symptoms clear up and occur again with a few days.
  • If sumptoms persist for more than seven days, discontinue use and consult physician.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, consult physician.


Advanced Ingredient Data


Raw Label Data

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