SUN BASICS BURN RELIEF GEL WITH LIDOCAINE- lidocaine gel

Sun basics by

Drug Labeling and Warnings

Sun basics by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hydrochloride (0.72%)

Purpose

Topical Analgesic

Uses

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

WARNINGS

For external use only.

When using this product Avoid contact with eyes

IF condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

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

Keep out of reach of children.

If product is swallowed, get medical help or contact a poison control center right away

When using this product

• Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

Do not use

• in large quantities, particularly over raw surfaces or blistered areas.

Stop use and contact a physician

• If irritation occurs.
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get 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 INGREDIENT

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Menthol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Sodium Hydroxide, Yellow 5, Water

Questions or Comments?

Biocycle Laboratories, Inc.

16363 BW 48 Avenue,

Miami, FL 33014

SUN basics Burn Relief with Lidocaine

INGREDIENTS AND APPEARANCE

SUN BASICS  BURN RELIEF GEL WITH LIDOCAINE
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0298
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	7.13 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0298-5	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	02/06/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0298) , manufacture(58443-0298) , label(58443-0298)