CORETEX ANTI-ITCH GEL- camphor, diphenhydramine, zinc acetate gel

CoreTex Anti-Itch Gel by

Drug Labeling and Warnings

CoreTex Anti-Itch Gel by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc, Cosmetic Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Purpose

Extrenal analgesic

Antihistamine

Skin protectant

Uses

• For the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac.
• dries the oozing and weeping of poison ivy, poison oak, poison sumac.

Warnings

For external use only

Do Not Use

• on chicken pox, blisters or on extensive areas of the skin
• with any drugs containing diphenhydramine while using this product.

When using this product

• keep out of eyes.

Stop use and ask a doctor if

• conditions worsen or 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 Poison Control center right away.

Directions

• Adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed bu a doctor.

Other Information

• protect this product from excessive heat and direct sun.

Inactive Ingredients

citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

Questions?

Call: 1-877-684-5774

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORETEX ANTI-ITCH GEL 
camphor, diphenhydramine, zinc acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.1 g  in 100 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 g  in 100 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-400-04	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2019
2	NDC: 65753-400-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2019
3	NDC: 65753-400-13	25 in 1 CONTAINER	11/26/2019
3		1 mL in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 65753-400-14	300 in 1 CONTAINER	11/26/2019
4		1 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/25/2019

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises		017701475	manufacture(65753-400)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	label(65753-400)