RENEWAL MEDICATED- menthol - dimethicone lotion
RITE AID

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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DRUG FACTS BOX(BACK LABEL)

ACTIVE INGREDIENTS

MENTHOL 0.5% (TOPICAL ANALGESIC)
DIMETHICONE 5.0% (SKIN PROTECTANT)

USES AND DIRECTIONS

USES: TO HELP MOISTURIZE, RELIEVE AND PROTECT DRY/ITCHY SKIN. RECOMMENDED FOR REPEATED USE.
DIRECTIONS: APPLY TO DRY, ITCHY SKIN AS OFTEN AS NEEDED

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

QUESTIONS/COMMENTS?

1-866-695-3030

PACKAGE FRONT AND BACK LABELS (14OZ)

14OZ FRONT AND BACK LABELS: ra14.jpg

RENEWAL MEDICATED
menthol - dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-3351
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 mL in 100 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	5.0 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-3351-4	414 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	07/14/2010

Labeler - RITE AID (014578892)