GENRX CALA ZINC SKIN HEALING- zinc oxide paste 
PureTek Corporation

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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Active ingredient

Zinc Oxide 20.0%

(3.0% as Calamine)

Purpose

Skin Protectant

Uses

■ for the treatment and/or prevention of diaper rash
■ temporarily protects and helps relieve minor skin irritation and itching due to rashes

Warnings

For external use only

Do not use on

■ deep or puncture wounds    ■ animal bites    ■ serious burns

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

■ cleanse skin with GenRx All Purpose Cleansing Lotion or Body Cleanser and apply paste to area as needed
■ for peri-G tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed

Other information

■ protect from freezing    ■ avoid excessive heat

Inactive ingredients

Aleurites moluccana seed oil, Aloe barbadensis (Aloe vera) leaf juice, Carthamus tinctorius (safflower) seed oil, fragrance, GenRx Complex™ [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], modified corn starch, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petrolatum, phenoxyethanol, sodium hyaluronate.

Cala Zinc Skin Healing Paste with GenRx Complex​TM (4 oz tube label)

GenRx Cala Zinc Skin Healing Paste 4 oz image

GENRX CALA ZINC SKIN HEALING 
zinc oxide paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-852
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
LEVOMENOL (UNII: 24WE03BX2T)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
GINGER (UNII: C5529G5JPQ)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59088-852-69 144 in 1 CARTON
1 NDC:59088-852-01 4 mL in 1 POUCH
2 NDC:59088-852-08 118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/08/2013
Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Business Operations
PureTek Corporation 785961046 manufacture(59088-852) , pack(59088-852) , label(59088-852)

Revised: 1/2013
Document Id: ca3e9b75-b2cb-47c7-8a57-af14be93351d
Set id: 20d9db50-4230-49a6-b522-186bf446aa96
Version: 1
Effective Time: 20130131
 
PureTek Corporation