RITE AID CALA ITCH RELIEF- pramoxine hcl 1%, zinc acetate 0.1% spray

Rite Aid Cala Itch Relief by

Drug Labeling and Warnings

Rite Aid Cala Itch Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine HCl 2%, Zinc Acetate 0.1%

PURPOSE

Topical Analgesic, Skin Protectant

INDICATIONS & USAGE

For the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. Dries the oozing and weeping of poison ivy, oak, and sumac.

WARNINGS

For external use only. Flammable--Keep away from fire or flame. Do not use on deep or puncture wounds, animal bites, or serious burns. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for 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.

DOSAGE & ADMINISTRATION

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor. To apply to face, spray into palm of hand and gently apply.

INACTIVE INGREDIENT

Alcohol Denat., Camphor, Citric Acid, Ethylhexylglycerin, Fragrance, glycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polysorbate 40, Propylene Glycol, Sodium Citrate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID CALA ITCH RELIEF 
pramoxine hcl 1%, zinc acetate 0.1% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-3101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 40 (UNII: STI11B5A2X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-3101-3	85 g in 1 CAN; Type 0: Not a Combination Product	03/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/31/2021

Labeler - Rite Aid (014578892)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(11822-3101)