ANTI-ITCH- menthol and pramoxine hydrochloride cream

Anti-Itch by

Drug Labeling and Warnings

Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc., Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

PURPOSE

Purpose

Anti-itch, Pain relief

INDICATIONS & USAGE

Uses

for temporary relief of pain and itching associated with:

• minor skin irritations
• minor cuts
• minor burns
• rashes due to poison ivy, poison oak or poison sumac
• scrapes
• insect bites

WARNINGS

Warnings

For external use only

Do not use on

• deep or puncture wounds
• animals bites
• serious burns
• large areas of the body

When using this product

• do not get into eyes or nose
• not for prolonged use

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
• if redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

INACTIVE INGREDIENT

Inactive ingredients

aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

SPL UNCLASSIFIED SECTION

Other information

• store at room temperature
• for lot no. and exp. date, see crimp of tube or see box

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH 
menthol and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-21 (UNII: 53J3F32P58)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
THYMOL (UNII: 3J50XA376E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-407-03	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 - Dolgencorp, Inc. (068331990)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(55910-407)