Active Ingredients

Camphor 0.1%

Diphenhydramine hydrochloride 2%

Zinc acetate 1%

Purpose

Extrenal analgesic

External analgesic

Skin protectant

Uses

For the temporary relief of itching and pain associated with minor cuts, minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and 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.
Avoid contact with the eyes
more than directed

When using the 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult 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: (877) 684-5774

Made in USA for CoreTex Products, Inc. Erwin, TN 37650 (877) 684-5774

PRINCIPAL DISPLAY PANEL
65753-400-02

400-02

Principal Display Panel
65753-400-04

400-04

Principal Display Panel
65753-13 and -14

400-1314

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/25/2019

Labeler - CoreTex Products Inc (061944620)

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

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

Cortex Anti-Itch Gel 65753-400