EQUATE SUNBURN RELIEF WITH ALOE AFTER SUN- lidocaine gel

EQUATE Sunburn relief with Aloe After Sun by

Drug Labeling and Warnings

EQUATE Sunburn relief with Aloe After Sun by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Only

Do not use in large quantities, particularly over raw surfaces or blistered areas

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.

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.

PRINCIPAL DISPLAY PANEL

Equate Sunburn Relief with Aloe After Sun Gel

INGREDIENTS AND APPEARANCE

EQUATE SUNBURN RELIEF WITH ALOE AFTER SUN 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-788
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MANGO (UNII: I629I3NR86)
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-788-20	567 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/18/2019

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(49035-788)