CLEAR ANTI ITCH- pramoxine hydrochloride and zinc acetate lotion 
Kroger Co

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.

----------

Drug Facts

Active Ingredients

Pramoxind HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Use

Warnings

For external use only

when using this product

do not get into eyes

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

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, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

questions or comments?

1-800-632-6900

Adverse reactions

DISTRIUBTED BY THE KROGER CO

CINCINNATI, OHIO 45202

www.kroger.com

disclaimer

Caladryl Clear is a registered trademark of Johnson + Johnson, Stillman, NJ 08558.  Johnson + Johnson is not affilaed with The Kroger Co. or this product.

Principal Display Panel

COMPARE TO the active ingredients of

CALADRYL CLEAR LOTION  see back panel

Kroger

FROM OUR FAMILY TO YOURS

Clear

anti-itch lotion

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:30142-218
Route of Administration TOPICAL DEA Schedule     
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 CATION 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-218-30 177 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/01/1994
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon Inc (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon, Inc 790752542 manufacture(30142-218)

Revised: 4/2013
Document Id: f6f078d9-4ca8-4e61-bd9e-62e4662bcdeb
Set id: 95a66433-6a68-4f3c-9aaa-4d27443aa7e5
Version: 1
Effective Time: 20130423
 
Kroger Co