NDC 49035-788 Equate Sunburn Relief With Aloe After Sun

Lidocaine

NDC Product Code 49035-788

NDC 49035-788-20

Package Description: 567 g in 1 BOTTLE

NDC Product Information

Equate Sunburn Relief With Aloe After Sun with NDC 49035-788 is a a human over the counter drug product labeled by Walmart Inc. The generic name of Equate Sunburn Relief With Aloe After Sun is lidocaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Walmart Inc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Equate Sunburn Relief With Aloe After Sun Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LIDOCAINE 8 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LAURETH-23 (UNII: N72LMW566G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CARBOMER 934 (UNII: Z135WT9208)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • MENTHYL D-LACTATE, (-)- (UNII: XFS8QYW6WY)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • MENTHOL (UNII: L7T10EIP3A)
  • ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
  • CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)
  • COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)
  • PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)
  • PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PIGMENT BLUE 1 (UNII: 4SBE571RQF)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walmart Inc
Labeler Code: 49035
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Equate Sunburn Relief With Aloe After Sun Product Label Images

Equate Sunburn Relief With Aloe After Sun Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Lidocaine 0.8% (as Lidocaine HCI)

Purpose

External Analgesic

Uses

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

Warnings

For External Use OnlyDo not use in large quantities, particularly over raw surfaces or blistered areasWhen 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.

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.

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 moluccanus 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.

Other

Sunburn Relief Gel with Aloe helps relieve the pain of irritated, sunburned skin. Medicated sunburn relief moisturizes skin on contact to help support skin’s natural moisture balance. Lidocaine helps bring fast relief to different skin irritations like sunburn, minor burns, minor cuts, scrapes, insect bites and windburn

* Please review the disclaimer below.

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