- Drug Facts:
- Active ingredients
- Purpose
- Uses
-
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.
- Directions
- Inactive ingredients
- Principal Display Panel .57 oz Tube
- Principal Display Panel -Can
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INGREDIENTS AND APPEARANCE
WELLY CALM BALM
anti itch cream creamProduct 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)