CLEAR ANTI ITCH- pramoxine hcl, zinc acetate lotion
Vi-Jon

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.

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Clear Anti-Itch Lotion

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Use

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 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 was affected are 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 of age - 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

This product is not manufactured or distributed by Valeant Pharmaceuticals, distributor of Caladryl*

Manufactured by:

Vi-Jon
One Swan Drive
Smyrna, TN 37167

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

principal display panel

SWAN

Clear Anti-itch Lotion

EXTERNAL ANALGESIC

SKIN PROTECTANT

For Relief from Pain and Itching due to:

Poison Ivy, Poison Sumac, Insect Bites, Poison Oak, + Minor Skin Irritatins

Compare to the active ingredients of Caladryl Clear*

6 FL OZ (177 mL)

image description

principal display panel

Mountain Falls

*Compare to Caladryl

Clear anti-itch lotion

external analgesic

skin protectant

Drying action plus itch relief

Relieves minor skin irritations

6 FL OZ (177 mL)

image description

CLEAR ANTI ITCH
pramoxine hcl, zinc acetate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0218
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0869-0218-30	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/1994

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/07/1994

Labeler - Vi-Jon (790752542)

Registrant - Vi-Jon Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(0869-0218)

Revised: 4/2020

Document Id: d46b2987-6d31-416b-8388-94547cde044a

Set id: 00a05a25-9219-45fd-91b7-3633c6303025

Version: 9

Effective Time: 20200417

Vi-Jon