MAXIMUM STRENGTH BURN RELIEF ALOE GEL SCHERER LABS- lidocaine hydrochloride 4.00% gel

Maximum Strength Burn Relief Aloe Gel by

Drug Labeling and Warnings

Maximum Strength Burn Relief Aloe Gel by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                            Purpose

Lidocaine Hydrochloride - 4.00%      Topical analgesic

PURPOSE

INDICATIONS & USAGE

Uses

For the temporary relief of pain and itching
due to sunburn minor burns insect bites
minor cuts scrapes minor skin irritation

WARNINGS

Warnings
For external use only.
When using this product avoid contact with
eyes. Rinse with water if contact occurs.
Stop use and ask doctor if if symptoms persist
for more than 7 days.
Do not use in large quantities, particularly over raw
surfaces or blistered areas.

Keep out of the reach of children

DOSAGE & ADMINISTRATION

Directions

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

INACTIVE INGREDIENT

Inactive ingredients

Aloe Barbadensis Leaf Extract, Avena
Sativa (Oat) Kernel Extract, Blue
1, Caprylyl Glycol, Chlorphenesin,
Dimethyl Isosorbide, Glycerin,
Hydroxyethylcellulose, Isopropyl
Alcohol, Phenoxyethanol,
Polysorbate 20, Propanediol,
Tocopheryl Acetate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH BURN RELIEF ALOE GEL  SCHERER LABS
lidocaine hydrochloride 4.00% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-5002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine Hydrochloride (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OAT (UNII: Z6J799EAJK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Caprylyl Glycol (UNII: 00YIU5438U)
Chlorphenesin (UNII: I670DAL4SZ)
Dimethyl Isosorbide (UNII: SA6A6V432S)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Alcohol (UNII: ND2M416302)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Propanediol (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-5002-4	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/08/2016

Labeler - Product Quest Mfg. (927768135)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(64048-5002) , label(64048-5002)