RUGID ITCH AND PAIN RELIEF- diphenhydramine hydrochloride and zinc acetate liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), Zinc Acetate (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)
Available from:
R & R Lotion, Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relieves pain and itching associated with: Insect Bites - Minor Burns - Minor Cuts - Sunburn - Minor Skin Irritations - Scrapes - Dries oozing and weeping of Poison Ivy, Poison Oak, and Poison Sumac - Rashes due to Poison Ivy, Poison Oak, and Poison Sumac.
Authorization status:
OTC monograph not final
Authorization number:
59555-010-18, 59555-010-19

RUGID ITCH AND PAIN RELIEF- diphenhydramine hydrochloride and zinc acetate liquid

R & R Lotion, Inc

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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Rugid Itch and Pain Relief

Drug Facts

Active Ingredients

Purpos e

Diphenhydramine HCL 2%

Topical Analgesic

Zinc Acetate 0.1%

Skin Protectant

Us es

Temporary relieves pain and itching associated with: Insect Bites

Minor Burns

Minor Cuts

Sunburn

Minor Skin Irritations

Scrapes

Dries oozing and weeping of Poison Ivy, Poison Oak, and Poison Sumac

Rashes due to Poison Ivy, Poison Oak, and Poison Sumac.

Warnings

For external use only. Do not use on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth.

Ask doctor before use on chicken pox

on measles

When using this product avoid contact with eyes

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.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right

away.

Directions

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

Protect from excessive heat (40ºC/104ºF)

Inactive Ingredients

Propylene Glycol, Xanthan Gum, DI Water, PVP K-30

Questions or Comments?

1-888-860-7424

PRINCIPAL DISPLAY PANEL - 20 ML Bottle Label

R&R LOTION INC.

RUGID

OUTDOORS

EST. 84

ITCH

& PAIN

RELIEF

STICK

MINOR CUTS,

BITES & BURNS

.76 FL. OZ. (20ML) e

Peel

Here

RUGID ITCH AND PAIN RELIEF

diphenhydramine hydrochloride and zinc acetate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 555-0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE -

UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

20 mg

in 1 mL

Zinc Aceta te (UNII: FM5526 K0 7A) (ZINC CATION - UNII:13S1S8 SF37)

Zinc Acetate

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

wa ter (UNII: 0 59 QF0 KO0 R)

Xa ntha n Gum (UNII: TTV12P4NEE)

R & R Lotion, Inc

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

PO VIDO NE K3 0 (UNII: U725QWY32X)

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:59 555-

0 10 -18

1 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 1/20 19

2

NDC:59 555-

0 10 -19

20 mL in 1 BOTTLE, WITH APPLICATOR; Type 0 : No t a

Co mbinatio n Pro duct

0 5/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 5/0 1/20 19

Labeler -

R & R Lotion, Inc (062979000)

Revised: 5/2019

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