Label: WELLY CALM BALM- anti itch cream cream
- NDC Code(s): 72663-069-50
- Packager: Welly Health PBC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated February 9, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts:
- Active ingredients
- Purpose
- Uses
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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)