LUCKY SUPERSOFT SUNBURN RELIEF- lidocaine hydrochloride gel

LUCKY SUPERSOFT by

Drug Labeling and Warnings

LUCKY SUPERSOFT by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine hydrochloride 0.5%

Purpose

External analgesic

Uses

temporarily relieves pain and itching associated with

■ sunburn ■ minor burns ■ minor cuts ■ scrapes ■ minor skin irritations ■ insect bites

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

Stop use and ask a doctor if

condition worsens

or if symptoms persist for more than 7 days

or symptoms clear up and occur again in a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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, glycerin, aloe barbadensis leaf juice, propylene glycol, menthol, disodium EDTA,isopropyl alcohol (0.06% v/v), polysorbate 20, carbomer, sodium hydroxide, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow no. 5, FD&C blue no. 1

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPERSOFT  SUNBURN RELIEF
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-110-06	170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2019
2	NDC: 20276-110-08	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/02/2019

Labeler - Delta Brands Inc (102672008)