PANAMA JACK BURN RELIEF GEL WITH LIDOCAINE- lidocaine gel

Panama Jack by

Drug Labeling and Warnings

Panama Jack 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 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

Other Information

• Protect from heat,
• Store at controlled room temperature.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, DMDM Hydantoin, Fragrance, Menthol, Methylparaben, Polysorbate 20, Propylene Glycol, SD Alcohol 40-B, Triethanolamine, Water, Yellow 5

Questions or Comments?

Email us at info@panamajack.com or call 1-800-840-5225

Panama Jack Burn Relief with Lidocaine

INGREDIENTS AND APPEARANCE

PANAMA JACK  BURN RELIEF GEL WITH LIDOCAINE
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0204
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)
SULISOBENZONE (UNII: 1W6L629B4K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0204-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/19/2015

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0204) , manufacture(58443-0204) , label(58443-0204)