WELLY CALM BALM- anti itch cream cream

Welly Calm Balm by

Drug Labeling and Warnings

Welly Calm Balm by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredients

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

For temporary relief from pain and itching associated with :

• insect bites
• minor burns
• sunburn
• minor skin irritations
• rashes due to poison ivy, poison oak, and poison sumac

Dries the oozing and weeping of poison

• ivy
• oak
• 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 the 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

• conditions worsen or does not improve within 7 days
• symptoms persist for more than 7 days or clear up and occur agian within a few days

Keep this and all drugs out of the reach of children.

If swallowed get medical help or contact a Poison Control Center immediately.

Directions

• do not use more than directed
• adults and children 2 years of age and older; apply to affected areas not more than 3 to 4 times daily
• children under 2 years of age , consult a doctor

Other Information

• Store at controlled room temperature 20°-25°C (68° - 77°F)
• Close the cap tightly after use

Inactive ingredients

Cetyl Alcohol, Citric Acid, Diazolldinyl Urea, Glyceryl Sterate, Methylparaben, Polyethylene Glycol Monosterate  1000, Propylene Glycol, Propylparaben, Sodium Citrate , Purified Water

Principal Display Panel .57 oz  Tube

 Welly First aid    NDC: 72663-069-59

Extra Strength ANTI -ITCH cream

2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g)

Principal Display Panel -Can 

Welly Calm Balm First aid NDC: 72663-069-59

Extra Strength ANTI -ITCH cream

2% Diphenhydramine HCL topical analgesic

0.1% Zinc Acetate skin protectant

NET WT 0.57 oz (16g) 

2- Tubes  1.14 oz ( 32g)

INGREDIENTS AND APPEARANCE

WELLY CALM BALM 
anti itch cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-069
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 CATION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-069-50	2 in 1 CAN	02/09/2019
1		16 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 final	part347	02/09/2019

Labeler - Welly Health PBC (116766884)

Registrant - Welly Health PBC (116766884)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(72663-069)