RPS CARE- allantoin, camphor cream
Lavior 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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Camphor 0.2%

Allantoin 0.5%

External Analgesic

Skin Protectant

Uses

Helps provide relief of symptoms of cold sores and dry lips

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

condition worsens
symptoms last 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 a Poison Control Center right away.

Directions

apply to lips not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Propanediol-1,3, Sodium Benzoate, Potassium Sorbate, Maltodextrin, Biosaccharide Gum-1, Bisabolol, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

RPS CARE

RPS CARE
allantoin, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71521-438
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM GLUCONATE (UNII: R6Q3791S76)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYL ALCOHOL (UNII: 936JST6JCN)
LEVOMENOL (UNII: 24WE03BX2T)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71521-438-30	1 in 1 BOX	02/27/2018	11/15/2018
1		30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/27/2018	11/15/2018

Labeler - Lavior Inc. (080685327)

Revised: 6/2021

Document Id: c3f88f60-08e1-352a-e053-2995a90a4b02

Set id: 6639c214-4b93-ddb5-e053-2a91aa0aedba

Version: 3

Effective Time: 20210604

Lavior Inc.