EXTRA STRENGTH ITCH STOPPING- itch stopping cream cream

Extra Strength by

Drug Labeling and Warnings

Extra Strength by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Centre LLC, Anicare Pharmaceutical Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

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

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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 avoid contact with eyes

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• 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 a Poison Control Center right away.

Directions

• do not use more than directed
• 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: ask a doctor

Other information

• protect from excessive heat (40°C/104°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

Questions?

Call toll-free 1-800-222-1222

SPL UNCLASSIFIED SECTION

Distributed by:

Universal Distribution Centre LLC

96 Distribution Boulevard, Edison
NJ 08817

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

EXTRA STRENGTH

Topical Analgesic/Skin Protectant

ITCH

STOPPING

CREAM

NET WT 1.25 OZ (35.4 g)

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH  ITCH STOPPING
itch stopping cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-071
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
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-071-04	1 in 1 CARTON	01/21/2021
1	NDC: 52000-071-03	35.4 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	M016	01/21/2021

Labeler - Universal Distribution Centre LLC (019180459)

Registrant - Savvy Care and Cosmetics Pvt. Ltd. (915039748)

Establishment
Name	Address	ID/FEI	Business Operations
Savvy Care and Cosmetics Pvt. Ltd.		915039748	manufacture(52000-071)