WELLY CALM BALM- anti itch cream cream 
Welly Health PBC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 :

Dries the oozing and weeping of poison

Warnings

For external use only

Do not use

Ask a Doctor before use

When using this product avoid contact with eyes.

Stop use and ask a doctor if

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

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

Directions

Other Information

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 .57 oz  Tube

Principal Display Panel .57 oz  Tube

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)

Principal Display Panel -Can

Principal Display Panel -Can

WELLY CALM BALM 
anti itch cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-069-502 in 1 CAN02/09/2019
116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/09/2019
Labeler - Welly Health PBC (116766884)
Registrant - Welly Health PBC (116766884)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(72663-069)

Revised: 2/2019
Document Id: a3d11002-6082-4737-95a0-d3ecd4a0c194
Set id: ac4c2623-6a84-4908-b018-956bb978aa56
Version: 1
Effective Time: 20190209
 
Welly Health PBC