RITE AID ORIGINAL STRENGTH VAGICAINE- benzocaine and resorcinol cream

Rite Aid Original Strength Vagicaine by

Drug Labeling and Warnings

Rite Aid Original Strength Vagicaine by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Benzocaine         5%

Resorcinol           2%

PURPOSE

Purpose

External analgesic

INDICATIONS & USAGE

Use

temporarily relieves itching

WARNINGS

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Do not apply over large areas of the body.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions
Adults and Children 12 years and older
 apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 or 4 times daily.

Children under 12 years
 ask a doctor

SPL UNCLASSIFIED SECTION

Other information

Store at 20° - 25 °C (68° - 77°F)

INACTIVE INGREDIENT

Inactive Ingredients

aloe vera gel, carbomer, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, mineral oil, methyl 4-hydroxybenzoate, PEG-100 stearate, propyl 4-hydroxybenzoate, propylene glycol, purified water, triethanolamine, vitamin A, D & E.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

RITE AID ORIGINAL STRENGTH VAGICAINE CREAM 

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

RITE AID ORIGINAL STRENGTH VAGICAINE 
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-9974
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-9974-2	28 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/30/2016

Labeler - Rite Aid Corporation (014578892)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(11822-9974)