ALCOHOLADA PAIN RELIEVING- lidocaine hydrochloride gel

Alcoholada Pain Relieving by

Drug Labeling and Warnings

Alcoholada Pain Relieving 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 quantities, 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 and 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 under 2 years of age: Consult a doctor.

Other Information

Store in a cool dry place

Protect from hear and light

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Vera (Aloe Barbadensis) Gel, Caprylyl Glycol, Chlorphenesin, FD&C Blue No.1, Fragrance (Parfum), Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water (Aqua).

Package Labeling:

INGREDIENTS AND APPEARANCE

ALCOHOLADA PAIN RELIEVING 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-164
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-164-00	251 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2017

Labeler - Aruba Aloe Balm NV (855442273)