ALCOHOLADA GEL PAIN RELIEVING PAIN- lidocaine hydrochloride gel

Alcoholada Gel Pain Relieving Pain by

Drug Labeling and Warnings

Alcoholada Gel Pain Relieving Pain by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine Hydrochloride 0.5%

Purpose

Pain Relieving Gel

Uses

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

Warnings

For external use only.

Do not use 

in large quantites, particularly over raw surfaces or blistered areas.

When using this product 

avoid contact with the eyes.

Stop use and ask a doctor if

conditions worsens, or if symptoms persist for more than 7 days or clears up nand occur again within 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 under2 years of age: Consult a doctor.

Other Information

• Store in a cool dry place
• Protect from heat and light

Inactive ingredients

Water (Aqua/Eau), Alcohol Denat. Polysorbate 20, Acrylates/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Sodium Hydroxide, FD&C #1 (C.I. 42090), Fragrance (Parfum)

Package Labeling:

INGREDIENTS AND APPEARANCE

ALCOHOLADA GEL PAIN RELIEVING PAIN 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-173-00	65 mL in 1 TUBE; Type 0: Not a Combination Product	10/25/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/25/2017

Labeler - Aruba Aloe Balm NV (855442273)

Establishment
Name	Address	ID/FEI	Business Operations
Aruba Aloe Balm NV		855442273	manufacture(53675-173)