Quality Choice Anti-Itch Medicated (Calamine And Pramoxine Hydrochloride) Lotion [Chain Drug Marketing Association Inc] -

QUALITY CHOICE ANTI-ITCH MEDICATED (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC	63868-420-96
Set ID	5e07f26f-cfb6-57f9-e053-2991aa0a2008
Category	HUMAN OTC DRUG LABEL
Packager	CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class
Product Number
Application Number	PART347

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Calamine 8%

Pramoxine HCl 1%
Purpose

Skin Protectant

External analgesic
Uses

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.
Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.
Stop ue and ask a doctor if

condition worsens. Symptoms last for more than 7days or clear up and occur again whitin a few days.
Keep out of reach of children.

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.
Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.
Inactive Ingredients

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.
Other information

Store at room temperature 15-30C (59-86F)
Label

INGREDIENTS AND APPEARANCE

QUALITY CHOICE ANTI-ITCH MEDICATED
calamine and pramoxine hydrochloride lotion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-420-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/25/1998

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc.		825672884	manufacture(63868-420) , analysis(63868-420) , pack(63868-420) , label(63868-420)

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