Label: INDUSTRIAL ITCH AND PAIN RELIEF- diphenhydramine hydrochloride and zinc acetate liquid
- NDC Code(s): 59555-002-18, 59555-002-19
- Packager: R & R Lotion, Inc
- 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.
Updated January 14, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
For external use only. Do not use on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth.
Stop use and ask doctor if conditions worsen, or do not improve within 7 days
- symptoms persist for more than 7 days or clear up and occur again within a few days.
Do not use more than directed
- Hold stick stright down over infected area
- press tip of stick repeatedly on affect skin area until liquid flows, then dab sparingly
- adults and children 2 years of age and older: apply to affected area not more then 3 to 4 times daily
- children under 2 years of age: ask a doctor
- Other Information
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label
INGREDIENTS AND APPEARANCE
INDUSTRIAL ITCH AND PAIN RELIEF
diphenhydramine hydrochloride and zinc acetate liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-002 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 mL Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) Zinc Acetate 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Propylene Glycol (UNII: 6DC9Q167V3) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-002-18 1 mL in 1 PACKET; Type 0: Not a Combination Product 05/01/2019 2 NDC:59555-002-19 20 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 05/01/2019 Labeler - R & R Lotion, Inc (062979000)