CARING MILL ANTI-ITCH CREAM- diphenhydramine hydrochloride and zinc acetate cream

Caring Mill Anti-Itch Cream by

Drug Labeling and Warnings

Caring Mill Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Active ingredients	Purpose
Diphenhydramine hydrochloride 2%	Topical analgesic
Zinc acetate 0.1%	Skin protectant

Uses

• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • minor skin irritations
  • rashes due to poison ivy, poison oak, oak, and sumac
• dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

For external use only

Do not use

• on large areas of the body
• with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

• on chicken pox
• on measles

When using this product

• use only as directed
• avoid contact with 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. (1-800-222-1222)

Directions

• adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician

Other information

• store at 20°C-25°C (68°C/77°F)
• do not use if tube seal under cap is broken

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium metabisulfite, water.

Questions?

toll-free 866-326-1313

Caring Mill Anti-Itch Cream

INGREDIENTS AND APPEARANCE

CARING MILL ANTI-ITCH CREAM 
diphenhydramine hydrochloride and zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
EDETATE SODIUM (UNII: MP1J8420LU)
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-055-01	1 in 1 CARTON	09/01/2024
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/01/2024

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(71101-055)