RITE AID LIDOCAINE ROLL ON- lidocaine hydrochloride liquid

Rite Aid Lidocaine Roll on by

Drug Labeling and Warnings

Rite Aid Lidocaine Roll on by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

temporarily relieves minor pain

Warnings

For external use only

Do not use

• on large areas of the body or on cut, irritated or swollen skin
  
• on puncture wounds
  
• for more than one week without consulting a doctor

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
  
• do not allow contact with the eyes
  
• do not bandage or apply local heat (such as heating pads) to area of use

Stop use and ask a doctor if

• condition worsens
  
• symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

• keep away from fire or flame

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

adults and children over 12 years:

• apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

children 12 years or younger: ask a doctor

Inactive ingredients

aloe vera gel, dimethicone, disodium EDTA, ethylhexylglycerin, methylparaben, C10-30 alkyl acrylate cross polymer, polysorbate 60, SD alcohol 40 (15%), triethanolamine, water

Child-resistant packaging. Close cap tightly after use. Keep carton as it contains important information.

Principal Display Panel

INGREDIENTS AND APPEARANCE

RITE AID LIDOCAINE ROLL ON 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-307
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-307-47	1 in 1 CARTON	03/01/2017
1		73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/01/2017

Labeler - Velocity Pharma LLC (962198409)