REESES PINWORM ITCH RELIEF- pramoxine hydrochloride cloth

Reeses by

Drug Labeling and Warnings

Reeses by is a Otc medication manufactured, distributed, or labeled by Reese Pharmaceutical Co, Guy & O'Neill, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pramoxine Hydrochloride 1.0% w/w

Purpose

ANALGESIC

Uses

• Temporarily relieves itching

Warnings

For external use only

When using this product

• Avoid contact with eyes

Stop use and ask a doctor if

• Condition worsens or does not improve within 7 days or clears up and reoccurs within a few days

Keep out of the reach of children.

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

Direction

• Adults: unfold wipe and cleanse the area by gently wiping or patting external area from front to back. Use each wipe only once and discard.
• Use up to 5 times daily.
• Children under 12: consult a doctor

Other information

• Store at room temperature
• Discard within 2 months of opening

Inactive ingredients

purified water, glycerin, propylene glycol, cocoamphodiacetate, polysorbate 20, aloe vera barbadensis leaf juice, citric acid, fragrance, diazolidinyl urea, iodopropynyl butylcarbamate.

Questions or comments?

1-800-321-7178

Images of representative packaging

INGREDIENTS AND APPEARANCE

REESES  PINWORM ITCH RELIEF
pramoxine hydrochloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10956-799
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10956-799-20	89 g in 1 PACKAGE; Type 0: Not a Combination Product	10/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/21/2013

Labeler - Reese Pharmaceutical Co (004172052)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Guy & O'Neill, Inc.		138513069	manufacture(10956-799) , label(10956-799)