Fruit Of The Earth Sun Town City Aloe Vera After Sun Gel With Lidocaine Hcl

Fruit Of The Earth Sun Town City Aloe Vera After Sun Gel With Lidocaine Hcl
SPL v2
SPL
SPL Set ID c7a833bd-7457-73a3-e053-2a95a90ac53f
Route
TOPICAL
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (8 mg)
Inactive Ingredients
Water Aloe Vera Leaf Alcohol Propylene Glycol Laureth-23 Polysorbate 20 Glycerin Allantoin .alpha.-tocopherol Acetate Phenoxyethanol Carbomer Interpolymer Type A (55000 Cps) Trolamine Menthyl Lactate, (-)- Benzyl Alcohol Edetate Disodium Menthol .alpha.-tocopherol, Dl- Plumeria Rubra Flower Mango Guava Papaya Passiflora Incarnata Flower Colocasia Esculenta Root Aleurites Moluccana Seed Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-09

Description

Lidocaine 0.8% (as Lidocaine HCl)

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Lidocaine 0.8% (as Lidocaine HCl)

Uses

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

Section 51945-4

Warnings

For External Use Only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Ask a doctor.
do Not Use

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredients

Lidocaine 0.8% (as Lidocaine HCl)

other Information:

May stain some fabrics.

inactive Ingredients:

water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccarnus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, Blue 1, Yellow 5.

when Using This Product

avoid contact with eyes. If contact occurs, rinse with water to remove.

stop Use and Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

keep Out of Reach of Children.

If swallowed, seek medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

External Analgesic

Warnings

For External Use Only

Directions
  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
  • Children under 2 years of age: Ask a doctor.
do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas

Active Ingredients

Lidocaine 0.8% (as Lidocaine HCl)

other Information: (Other information:)

May stain some fabrics.

inactive Ingredients: (Inactive ingredients:)

water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccarnus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, Blue 1, Yellow 5.

when Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse with water to remove.

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

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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