Anti-Itch: Package Insert and Label Information

ANTI-ITCH- menthol and pramoxine hydrochloride cream
Dolgencorp, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Anti-itch, Pain relief

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

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.

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 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

Other information

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

PRINCIPAL DISPLAY PANEL

ANTI-ITCH CREAM

NET WT 1 OZ (28 g)

ANTI-ITCH menthol and pramoxine hydrochloride cream

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1 g in 100 g PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF DIAZOLIDINYL UREA EDETATE DISODIUM EUCALYPTOL IODOPROPYNYL BUTYLCARBAMATE METHYL SALICYLATE MINERAL OIL PETROLATUM PPG-1 TRIDECETH-6 PROPYLENE GLYCOL STEARETH-21 STEARYL ALCOHOL THYMOL .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55910-407-03 28 g in 1 TUBE None

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	Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture (55910-407)

Revised: 07/2016 Dolgencorp, Inc.