Label: OLP ANTI-ITCH ALLERGY RELIEF- diphenhydramine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70648-133-01 - Packager: OHIO LAB PHARMA LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 November 26, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- Uses
- warnings
- do not use
- Ask a doctor before use
- WHEN USING
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- inactive ingredients
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OLP ANTI-ITCH ALLERGY RELIEF
diphenhydramine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70648-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 10 mg in 1 g ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE 1 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) DECYL OLEATE (UNII: ZGR06DO97T) SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) TROLAMINE (UNII: 9O3K93S3TK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) EDETATE DISODIUM (UNII: 7FLD91C86K) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70648-133-01 1 in 1 CARTON 02/21/2018 1 20 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 not final part348 02/21/2018 Labeler - OHIO LAB PHARMA LLC. (080215854) Establishment Name Address ID/FEI Business Operations OHIO LAB PHARMA LLC. 080215854 manufacture(70648-133)