CLEAR ANTI ITCH- pramoxine hcl, zinc acetate lotion 
Major Pharmaceuticals

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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Major 218.001/218AE  Clear Anti-Itch Lotion

Active Ingredients

Pramoxine HCl 1%

Zinc acetate 0.1%

Purpose

External analgesic

Skin protectant

Use

  • for the temporary relief oc 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, hypromellose, methylparaben, oil of lavender, oil of rosemary, polysorbate 40, propylene glycol, propylparaben, purified water, sodium citrate

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

Distributed By
MAJOR PHARMACEUTICALS
31778 ENTERPRISE DRIVE
LIVONIA, MI 48150
SERIOUS SIDE EFFECTS ASSOCIATED WITH USE OF THIS PRODUCT MAY BE REPORTED TO: 1-800-616-2471

principal panel display

MAJOR

NDC 0904-7760-21

Callergy CLEAR LOTION

External Analgesic/Skin Protectant

For Relief from Pain and Itching Due to:

  • Poison Ivy
  • Poison Sumac
  • Minor Skin Irritation
  • Insect Bites
  • Poison Oak

Compare to Active Ingredient of Caladryl Clear Lotion*

6 FL OZ (177 mL)

image description

CLEAR ANTI ITCH 
pramoxine hcl, zinc acetate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7760
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSE, UNSPECIFIED (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7760-21177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/199512/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/18/199512/15/2022
Labeler - Major Pharmaceuticals (191427277)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0904-7760)

Revised: 12/2022
 
Major Pharmaceuticals