VIDA MIA CALACLEAR- zinc acetate and pramoxine hydrochloride lotion
Navarro Discount Pharmacies, LLC

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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Vida Mia Calaclear Lotion

Drug Facts

Active Ingredients

Zinc Acetate 8%

Pramoxine HCl 1%

Purpose

Skin Protectant

External analgesic

Uses

Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and sumac or other skin irritations.

Warnings

For external use only. Use only as directed.

When using this product. Avoid contact with eyes and moucous membranes.

Ask a doctor before using on children 2 years of age.

Stop use and ask a doctor if

condition worsens. Symptoms last for more than 7 days or clear up and occur again whitin a few days.

Keep out of reach of children.

In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center immediately.

Directions

Adults and children 2 yr. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry. Apply to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.

Children under 2 yrs. of age. Consult a doctor before use.

Inactive Ingredients

SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin, Hydroxypropyl Methycelulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben and Purified Water.

Other information

Store at room temperature 15-30C (59-86F)

Label

VIDA MIA CALACLEAR
zinc acetate and pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59970-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59970-400-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/09/2017	11/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/09/2017	11/09/2018

Labeler - Navarro Discount Pharmacies, LLC (094930963)

Registrant - Humco Holding Group, Inc. (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc		825672884	analysis(59970-400) , manufacture(59970-400) , pack(59970-400) , label(59970-400)

Revised: 11/2018

Document Id: 7a3f2944-2f7c-4759-e053-2a91aa0ac4b3

Set id: 5d9038b7-aec8-d148-e053-2991aa0a07f4

Version: 2

Effective Time: 20181109

Navarro Discount Pharmacies, LLC