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, benzoic acid, camphor, citric acid, fragrance, glycerin, hydroxypropyl methylcellulose, Lavandula angustifolia (lavender) oil, polysorbate 40, Rosmarinus officinalis (rosemary) leaf oil, sodium citrate, water

Disclaimer

*This product is not manufactured or distributed by Bausch Health US, LLC, distributor of Caladryl® Clear® Lotion.

Adverse reaction

Distributed by: Perrigo Direct, Inc.

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

GoodSense is a registed trademark of L. Perrigo Company.

Principal Display Panel

NDC: 11344-218-30

GoodSENSE®

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)

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)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
POLYSORBATE 40 (UNII: STI11B5A2X)
ROSEMARY OIL (UNII: 8LGU7VM393)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

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 Drug	M016	07/24/2008

Labeler - Consumer Product Partners, LLC (119091520)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(11344-218)