GOOD SENSE BURN RELIEF ALOE- lidocaine hcl gel

Good Sense Burn Relief Aloe by

Drug Labeling and Warnings

Good Sense Burn Relief Aloe by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 0.5%

PURPOSE

External Analgesic.

DOSAGE & ADMINISTRATION

For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, 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. Rinse with water if contact occurs.

Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: consult a physician.

INACTIVE INGREDIENT

Water, Glycerin, Isopropyl Alcohol, Aloe Barbadensis Leaf Extract, Menthol, Propylene Glycol, Polysorbate 80, Triethanolamine, Carbomer, Disodium EDTA, Blue 1, Yellow 5, Diazolidinyl Urea.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOOD SENSE BURN RELIEF ALOE 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-955
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-955-08	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/04/2020

Labeler - Geiss, Destin & Dunn, Inc (076059836)