CLEAR ANTI-ITCH- pramoxine hcl, zinc acetate lotion

Clear Anti-Itch by

Drug Labeling and Warnings

Clear Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Uses

• for the temporary relief of pain and itching associated with minor skin irritations and rashes due to poison ivy, poison oak or poison sumac
• dries the oozing and weeping of poison: - ivy - oak - sumac

Warnings

For external use only

When using this product

• do not get into eyes

Stop use section and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

• shake well
• before applying wash affected area of skin

adults and children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years - ask a doctor

Other information

store at room temperature (59° - 77° F)

Inactive ingredients

alcohol, camphor, citric acid, diazolidinyl urea, fragrance, glycerin, hydroxypropyl methylcellulose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben purified water, sodium citrate

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Caladryl Clear Lotion.

Distributed by Vi-Jon

8515 Page Ave.

St. Louis, MO 63114

DSP-TN-15000  DSP-MO-34  SDS-TN-15012

Principal Display Panel

NDC: 11344-218-30

Clear Anti-Itch Lotion

EXTERNAL ANALGESIC/SKIN PROTECTANT

Pain and itch reliever

*Compare to active ingredients of Caladryl Clear Lotion

6 FL OZ (177 mL)

218.001/218AE

INGREDIENTS AND APPEARANCE

CLEAR ANTI-ITCH 
pramoxine hcl, zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-218
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 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
POLYSORBATE 40 (UNII: STI11B5A2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-218-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	07/24/2008

Labeler - Vi-Jon, LLC (790752542)

Registrant - Vi-Jon, LLC (088520668)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, LLC		790752542	manufacture(11344-218)